Mediaid Inc 17517 Fabrica Way Suite H, Cerritos, CA 90703, USA 

Full Quality Assurance System Approval Certificate Annex II, section 3 of Council Directive 93/42/EEC concerning medical devices

Scope of Certificate: Supply of Vital Signs Monitors and SPO2 disposable and reusable probes

Device Classification: Class IIa and IIb

Device Descriptions: Vital Signs Monitors and SPO2 disposable and reusable probes

Model Type: Please refer to Attachments 1 – 8

File Number A17030 Cycle Start Date 22 August 2011

Certificate No. 581.110822 Effective Date 22 August 2011

Expiry Date 02 June 2014

 

Authorised by

 Ivor Barrett

Certification Manager For and on Behalf of UL International (UK) Ltd

We hereby declare that an examination of the full quality assurance system has been carried out per report 11CA31895, following the requirements of the national legislation to which the undersigned is subject, transposing Annex II (with the exemption of section 4) of Council Directive 93/42/EEC on Medical Devices. We certify that the full quality assurance system conforms with the relevant provisions of the aforementioned directive and is subject to periodic surveillance as required by 93/42/EEC. Annex II, Section 5. For Class III devices where they are covered by this certificate, an EC Design Examination certificate according to 93/42/EEC, Annex II, Section 4 is required. This certificate is issued with 8 attachments listing model numbers and 0 addendums listing additional locations covered by this certificate.

Notified Body

0843

OBL 00-NB-F0408 1.0

      

Mediaid Inc 17517 Fabrica Way Suite H, Cerritos, CA 90703, USA

Attachment 1 of 8

The products detailed below are covered under the scope of this certificate

Product Family Product Sub-Group OBL Model Classification

Pulse Oximeters M30 - Pulse Oximeter for spot measurement

POX010-30 Class IIb

M31 - Pulse Oximeter with alarm

POX010-31 Class IIb

M32 - Pulse Oximeter with alarm, memory & USB for data download

POX010-32 Class IIb

M33 - Pulse Oximeter with alarm, memory & IR for data transfer and printing

POX010-33 Class IIb

M34 - Pulse Oximeter with alarm, memory & USB for data download and IR for data transfer and printing

POX010-34 Class IIb

M35 - Model M34 with any combination of alarm, memory, USB & IR with Pulse oximeter

POX010-35 Class IIb

M36 - Model M34 with any combination of alarm, memory, USB & IR with Pulse Oximeter operating with non-chargeable battery

POX010-36 Class IIb

Vital Signs Monitors M900 - SpO2 Monitor POX010-900 Class IIb M900P - SpO2 Monitor with Printer

POX010-900P Class IIb

M900NC - SpO2 Monitor without communication module

POX010-900NC Class IIb

M960 - Multiparameter (SpO2, Ni-BP & Temperature) Monitor

POX010-960 Class IIb

M960P - Multiparameter (SpO2, Ni-BP & Temperature) Monitor with thermal Printer

POX010-960P Class IIb

File Number A17030 Cycle Start Date 22 August 2011 Certificate No. 581.110822 Effective Date 22 August 2011

Expiry Date 02 June 2014

 

Authorised by

Ivor Barrett

Certification Manager For and on Behalf of UL International (UK) Ltd

Notified Body

0843

OBL 00-NB-F0408 1.0

      

Mediaid Inc 17517 Fabrica Way Suite H, Cerritos, CA 90703, USA

Attachment 2 of 8

The products detailed below are covered under the scope of this certificate

Product Family Classification

Disposable Customised Sensors: Disposable Sensors with Foam Tape – Foam/Foam Type

SI #

Adult 45cm

Pediatric 45cm

Infant 90cm

Neonatal 90cm

Class IIa

1 CST020-2301 CST020-2302 CST020-2303 CST020-2304

2 CST020-2401 CST020-2402 CST020-2403 CST020-2404

3 CST020-2901 CST020-2902 CST020-2903 CST020-2904

4 CST020-2501 CST020-2502 CST020-2503 CST020-2504

5 CST020-2151 CST020-2152 CST020-2153 CST020-2154

6 CST020-2121 CST020-2122 CST020-2123 CST020-2124

7 CST020-2801 CST020-2802 CST020-2803 CST020-2804

8 CST020-2701 CST020-2702 CST020-2703 CST020-2704

9 CST020-2601 CST020-2602 CST020-2603 CST020-2604

10 CST020-2201  CST020-2202 CST020-2203 CST020-2204

Disposable Sensors with Foam Tape – Foam/Foam Cloth

SI #

Adult 45cm

Pediatric 45cm

Infant 90cm

Neonatal 90cm

Class IIa

1 CST030-2301 CST030-2302 CST030-2303 CST030-2304

2 CST030-2401 CST030-2402 CST030-2403 CST030-2404

3 CST030-2901 CST030-2902 CST030-2903 CST030-2904

4 CST030-2501 CST030-2502 CST030-2503 CST030-2504

5 CST030-2151 CST030-2152 CST030-2153 CST030-2154

6 CST030-2121 CST030-2122 CST030-2123 CST030-2124

7 CST030-2801 CST030-2802 CST030-2803 CST030-2804

8 CST030-2701 CST030-2702 CST030-2703 CST030-2704

9 CST030-2601 CST030-2602 CST030-2603 CST030-2604

10 CST030-2201 CST030-2202 CST030-2203 CST030-2204

File Number A17030 Cycle Start Date 22 August 2011 Certificate No. 581.110822 Effective Date 22 August 2011

Expiry Date 02 June 2014

 

Authorised by

Ivor Barrett

Certification Manager For and on Behalf of UL International (UK) Ltd

Notified Body

0843

OBL 00-NB-F0408 1.0

      

Mediaid Inc 17517 Fabrica Way Suite H, Cerritos, CA 90703, USA

Attachment 3 of 8

The products detailed below are covered under the scope of this certificate

Product Family Classification

Disposable Customised Sensors: Disposable Sensors with Fabric Tape (Medaplast)

SI #

Adult 45cm

Pediatric 45cm

Infant 90cm

Neonatal 90cm

Class IIa

1 CST034-2301 CST034-2302 CST034-2303 CST034-2304

2 CST034-2401 CST034-2402 CST034-2403 CST034-2404

3 CST034-2901 CST034-2902 CST034-2903 CST034-2904

4 CST034-2501 CST034-2502 CST034-2503 CST034-2504

5 CST034-2151 CST034-2152 CST034-2153 CST034-2154

6 CST034-2121 CST034-2122 CST034-2123 CST034-2124

7 CST034-2801 CST034-2802 CST034-2803 CST034-2804

8 CST034-2701 CST034-2702 CST034-2703 CST034-2704

9 CST034-2601 CST034-2602 CST034-2603 CST034-2604

10 CST034-2201  CST034-2202 CST034-2203 CST034-2204

Disposable Sensors with Fabric Tape (Medaplast) Old

SI #

Adult 45cm

Pediatric 45cm

Infant 90cm

Neonatal 90cm

Class IIa

1 CST036-2301 CST036-2302 CST036-2303 CST036-2304

2 CST036-2401 CST036-2402 CST036-2403 CST036-2404

3 CST036-2901 CST036-2902 CST036-2903 CST036-2904

4 CST036-2501 CST036-2502 CST036-2503 CST036-2504

5 CST036-2151 CST036-2152 CST036-2153 CST036-2154

6 CST036-2121 CST036-2122 CST036-2123 CST036-2124

7 CST036-2801 CST036-2802 CST036-2803 CST036-2804

8 CST036-2701 CST036-2702 CST036-2703 CST036-2704

9 CST036-2601 CST036-2602 CST036-2603 CST036-2604

10 CST036-2201 CST036-2202 CST036-2203 CST036-2204

File Number A17030 Cycle Start Date 22 August 2011 Certificate No. 581.110822 Effective Date 22 August 2011

Expiry Date 02 June 2014

 

Authorised by

Ivor Barrett

Certification Manager For and on Behalf of UL International (UK) Ltd

Notified Body

0843

OBL 00-NB-F0408 1.0

      

Mediaid Inc 17517 Fabrica Way Suite H, Cerritos, CA 90703, USA

Attachment 4 of 8

The products detailed below are covered under the scope of this certificate

Product Family Classification

Disposable Customised Sensors: Disposable Sensors with Transpore Tape

SI #

Adult 45cm

Pediatric 45cm

Infant 90cm

Neonatal 90cm

Class IIa

1 CST032-2301 CST032-2302 CST032-2303 CST032-2304

2 CST032-2401 CST032-2402 CST032-2403 CST032-2404

3 CST032-2901 CST032-2902 CST032-2903 CST032-2904

4 CST032-2501 CST032-2502 CST032-2503 CST032-2504

5 CST032-2151 CST032-2152 CST032-2153 CST032-2154

6 CST032-2121 CST032-2122 CST032-2123 CST032-2124

7 CST032-2801 CST032-2802 CST032-2803 CST032-2804

8 CST032-2701 CST032-2702 CST032-2703 CST032-2704

9 CST032-2601 CST032-2602 CST032-2603 CST032-2604

10 CST032-2201  CST032-2202 CST032-2203 CST032-2204

Disposable Non Adhesive Sensors with Velcro Tape

SI #

Adult 45cm

Pediatric 45cm

Infant 90cm

Neonatal 90cm

Class IIa

1 CST050-2301 CST050-2302 CST050-2303 CST050-2304

2 CST050-2401 CST050-2402 CST050-2403 CST050-2404

3 CST050-2901 CST050-2902 CST050-2903 CST050-2904

4 CST050-2501 CST050-2502 CST050-2503 CST050-2504

5 CST050-2151 CST050-2152 CST050-2153 CST050-2154

6 CST050-2121 CST050-2122 CST050-2123 CST050-2124

7 CST050-2801 CST050-2802 CST050-2803 CST050-2804

8 CST050-2701 CST050-2702 CST050-2703 CST050-2704

9 CST050-2601 CST050-2602 CST050-2603 CST050-2604

10 CST050-2201 CST050-2202 CST050-2203 CST050-2204

File Number A17030 Cycle Start Date 22 August 2011 Certificate No. 581.110822 Effective Date 22 August 2011

Expiry Date 02 June 2014

 

Authorised by

Ivor Barrett

Certification Manager For and on Behalf of UL International (UK) Ltd

Notified Body

0843

OBL 00-NB-F0408 1.0

      

Mediaid Inc 17517 Fabrica Way Suite H, Cerritos, CA 90703, USA

Attachment 5 of 8

The products detailed below are covered under the scope of this certificate

Product Family Classification

Reusable Customised Sensors: S #

Adult Finger Sensor

Pedi Finger Sensor

Ear Sensor Y-Sensor Soft Adult Soft Pedi Class IIa

1 CST060-3101 CST062-3101 CST064-3101 CST070-3101 CST100-3101 CST102-3101

CST060-31019 CST062-31019 CST064-31019 CST070-31019 CST100-31019 CST102-31019

CST060-31011 CST062-31011 CST064-31011 CST070-31011 CST100-31011 CST102-31011

2 CST060-3103 CST062-3103 CST064-3103 CST070-3103 CST100-3103 CST102-3103

CST060-31039 CST062-31039 CST064-31039 CST070-31039 CST100-31039 CST102-31039

CST060-31031 CST062-31031 CST064-31031 CST070-31031 CST100-31031 CST102-31031

3 CST060-3104 CST062-3104 CST064-3104 CST070-3104 CST100-3104 CST102-3104

CST060-31049 CST062-31049 CST064-31049 CST070-31049 CST100-31049 CST102-31049

CST060-31041 CST062-31041 CST064-31041 CST070-31041 CST100-31041 CST102-31041

4 CST060-3105 CST062-3105 CST064-3105 CST070-3105 CST100-3105 CST102-3105

CST060-31059 CST062-31059 CST064-30159 CST070-31059 CST100-30159 CST102-31059

CST060-31051 CST062-31051 CST064-31051 CST070-31051 CST100-31051 CST102-31051

5 CST060-3108 CST062-3108 CST064-3108 CST070-3108 CST100-3108 CST102-3108

CST060-31089 CST062-31089 CST064-31089 CST070-31089 CST100-31089 CST102-31089

CST060-31081 CST062-31081 CST064-31081 CST070-31081 CST100-31081 CST102-31081

6 CST060-3155 CST062-3155 CST064-3155 CST070-3155 CST100-3155 CST102-3155

CST060-31559 CST062-31559 CST064-31559 CST070-31559 CST100-31559 CST102-31559

CST060-31551 CST062-31551 CST064-31551 CST070-31551 CST100-31551 CST102-31551

7 CST060-3106 CST062-3106 CST064-3106 CST070-3106 CST100-3106 CST102-3106

CST060-31069 CST062-31069 CST064-31069 CST070-31069 CST100-31069 CST102-31069

CST060-31061 CST062-31061 CST064-31061 CST070-31061 CST100-31061 CST102-31061

8 CST060-3107 CST062-3107 CST064-3107 CST070-3107 CST100-3107 CST102-3107

CST060-31079 CST062-31079 CST064-31079 CST070-31079 CST100-31079 CST102-31079

CST060-31071 CST062-31071 CST064-31071 CST070-31071 CST100-31071 CST102-31071

9 CST060-3136 CST062-3136 CST064-3136 CST070-3136 CST100-3136 CST102-3136

CST060-31369 CST062-31369 CST064-31369 CST070-31369 CST100-31369 CST102-31369

CST060-31361 CST062-31361 CST064-31361 CST070-31361 CST100-31361 CST102-31361

File Number A17030 Cycle Start Date 22 August 2011 Certificate No. 581.110822 Effective Date 22 August 2011

Expiry Date 02 June 2014

 

Authorised by

Ivor Barrett

Certification Manager For and on Behalf of UL International (UK) Ltd

Notified Body

0843

OBL 00-NB-F0408 1.0

      

Mediaid Inc 17517 Fabrica Way Suite H, Cerritos, CA 90703, USA

Attachment 6 of 8

The products detailed below are covered under the scope of this certificate

Product Family Classification

Reusable Customised Sensors: S #

Adult Finger Sensor

Pedi Finger Sensor

Ear Sensor Y-Sensor Soft Adult Soft Pedi Class IIa

10 CST060-3109 CST062-3109 CST064-3109 CST070-3109 CST100-3109 CST102-3109

CST060-31099 CST062-31099 CST064-31099 CST070-31099 CST100-31099 CST102-31099

CST060-31091 CST062-31091 CST064-31091 CST070-31091 CST100-31091 CST102-31091

11 CST060-3110 CST062-3110 CST064-3110 CST070-3110 CST100-3110 CST102-3110

CST060-31109 CST062-31109 CST064-31109 CST070-31109 CST100-31109 CST102-31109

CST060-31101 CST062-31101 CST064-31101 CST070-31101 CST100-31101 CST102-31101

12 CST060-3113 CST062-3113 CST064-3113 CST070-3113 CST100-3113 CST102-3113

CST060-31139 CST062-31139 CST064-31139 CST070-31139 CST100-31139 CST102-31139

CST060-31131 CST062-31131 CST064-31131 CST070-31131 CST100-31131 CST102-31131

13 CST060-3114 CST062-3114 CST064-3114 CST070-3114 CST100-3114 CST102-3114

CST060-31149 CST062-31149 CST064-31149 CST070-31149 CST100-31149 CST102-31149

CST060-31141 CST062-31141 CST064-31141 CST070-31141 CST100-31141 CST102-31141

14 CST060-3116 CST062-3116 CST064-3116 CST070-3116 CST100-3116 CST102-3116

CST060-31169 CST062-31169 CST064-31169 CST070-31169 CST100-31169 CST102-31169

CST060-31161 CST062-31161 CST064-31161 CST070-31161 CST100-31161 CST102-31161

15 CST060-3157 CST062-3157 CST064-3157 CST070-3157 CST100-3157 CST102-3157

CST060-31579 CST062-31579 CST064-31579 CST070-31579 CST100-31579 CST102-31579

CST060-31571 CST062-31571 CST064-31571 CST070-31571 CST100-31571 CST102-31571

16 CST060-3141 CST062-3141 CST064-3141 CST070-3141 CST100-3141 CST102-3141

CST060-31419 CST062-31419 CST064-31419 CST070-31419 CST100-31419 CST102-31419

CST060-31411 CST062-31411 CST064-31411 CST070-31411 CST100-31411 CST102-31411

17 CST060-3143 CST062-3143 CST064-3143 CST070-3143 CST100-3143 CST102-3143

CST060-31439 CST062-31439 CST064-31439 CST070-31439 CST100-31439 CST102-31439

CST060-31431 CST062-31431 CST064-31431 CST070-31431 CST100-31431 CST102-31431

18 CST060-3135 CST062-3135 CST064-3135 CST070-3135 CST100-3135 CST102-3135

CST060-31359 CST062-31359 CST064-31359 CST070-31359 CST100-31359 CST102-31359

CST060-31351 CST062-31351 CST064-31351 CST070-31351 CST100-31351 CST102-31351

File Number A17030 Cycle Start Date 22 August 2011 Certificate No. 581.110822 Effective Date 22 August 2011

Expiry Date 02 June 2014

 

Authorised by

Ivor Barrett

Certification Manager For and on Behalf of UL International (UK) Ltd

Notified Body

0843

OBL 00-NB-F0408 1.0

      

Mediaid Inc 17517 Fabrica Way Suite H, Cerritos, CA 90703, USA

Attachment 7 of 8

The products detailed below are covered under the scope of this certificate

Product Family Classification

Reusable Customised Sensors: S #

Adult Finger Sensor

Pedi Finger Sensor

Ear Sensor Y-Sensor Soft Adult Soft Pedi Class IIa

19 CST060-3132 CST062-3132 CST064-3132 CST070-3132 CST100-3132 CST102-3132

CST060-31329 CST062-31329 CST064-31329 CST070-31329 CST100-31329 CST102-31329

CST060-31321 CST062-31321 CST064-31321 CST070-31321 CST100-31321 CST102-31321

20 CST060-3145 CST062-3145 CST064-3145 CST070-3145 CST100-3145 CST102-3145

CST060-31459 CST062-31459 CST064-31459 CST070-31459 CST100-31459 CST102-31459

CST060-31451 CST062-31451 CST064-31451 CST070-31451 CST100-31451 CST102-31451

21 CST060-3152 CST062-3152 CST064-3152 CST070-3152 CST100-3152 CST102-3152

CST060-31529 CST062-31529 CST064-31529 CST070-31529 CST100-31529 CST102-31529

CST060-31521 CST062-31521 CST064-31521 CST070-31521 CST100-31521 CST102-31521

22 CST060-3151 CST062-3151 CST064-3151 CST070-3151 CST100-3151 CST102-3151

CST060-31519 CST062-31519 CST064-31519 CST070-31519 CST100-31519 CST102-31519

CST060-31511 CST062-31511 CST064-31511 CST070-31511 CST100-31511 CST102-31511

23 CST060-3162 CST062-3162 CST064-3162 CST070-3162 CST100-3162 CST102-3162

CST060-31629 CST062-31629 CST064-31629 CST070-31629 CST100-31629 CST102-31629

CST060-31621 CST062-31621 CST064-31621 CST070-31621 CST100-31621 CST102-31621

24 CST060-3120 CST062-3120 CST064-3120 CST070-3120 CST100-3120 CST102-3120

CST060-31209 CST062-31209 CST064-31209 CST070-31209 CST100-31209 CST102-31209

CST060-31201 CST062-31201 CST064-31201 CST070-31201 CST100-31201 CST102-31201

25 CST060-3121 CST062-3121 CST064-3121 CST070-3121 CST100-3121 CST102-3121

CST060-31219 CST062-31219 CST064-31219 CST070-31219 CST100-31219 CST102-31219

CST060-31219 CST062-31219 CST064-31219 CST070-31219 CST100-31219 CST102-31219

26 CST060-3123 CST062-3123 CST064-3123 CST070-3123 CST100-3123 CST102-3123

CST060-31239 CST062-31239 CST064-31239 CST070-31239 CST100-31239 CST102-31239

CST060-31231 CST062-31231 CST064-31231 CST070-31231 CST100-31231 CST102-31231

27 CST060-3124 CST062-3124 CST064-3124 CST070-3124 CST100-3124 CST102-3124

CST060-31249 CST062-31249 CST064-31249 CST070-31249 CST100-31249 CST102-31249

CST060-31241 CST062-31241 CST064-31241 CST070-31241 CST100-31241 CST102-31241

File Number A17030 Cycle Start Date 22 August 2011 Certificate No. 581.110822 Effective Date 22 August 2011

Expiry Date 02 June 2014

 

Authorised by

Ivor Barrett

Certification Manager For and on Behalf of UL International (UK) Ltd

Notified Body

0843

OBL 00-NB-F0408 1.0

      

Mediaid Inc 17517 Fabrica Way Suite H, Cerritos, CA 90703, USA

Attachment 8 of 8

The products detailed below are covered under the scope of this certificate

Product Family Classification

Reusable Customised Sensors: S #

Adult Finger Sensor

Pedi Finger Sensor

Ear Sensor Y-Sensor Soft Adult Soft Pedi Class IIa

28 CST060-3125 CST062-3125 CST064-3125 CST070-3125 CST100-3125 CST102-3125

CST060-31259 CST062-31259 CST064-31259 CST070-31259 CST100-31259 CST102-31259

CST060-31251 CST062-31251 CST064-31251 CST070-31251 CST100-31251 CST102-31251

29 CST060-3126 CST062-3126 CST064-3126 CST070-3126 CST100-3126 CST102-3126

CST060-31269 CST062-31269 CST064-31269 CST070-31269 CST100-31269 CST102-31269

CST060-31261 CST062-31261 CST064-31261 CST070-31261 CST100-31261 CST102-31261

30 CST060-3128 CST062-3128 CST064-3128 CST070-3128 CST100-3128 CST102-3128

CST060-31289 CST062-31289 CST064-31289 CST070-31289 CST100-31289 CST102-31289

CST060-31281 CST062-31281 CST064-31281 CST070-31281 CST100-31281 CST102-31281

31 CST060-3130 CST062-3130 CST064-3130 CST070-3130 CST100-3130 CST102-3130

CST060-31309 CST062-31309 CST064-31309 CST070-31309 CST100-31309 CST102-31309

CST060-31301 CST062-31301 CST064-31301 CST070-31301 CST100-31301 CST102-31301

32 CST060-3131 CST062-3131 CST064-3131 CST070-3131 CST100-3131 CST102-3131

CST060-31319 CST062-31319 CST064-31319 CST070-31319 CST100-31319 CST102-31319

CST060-31311 CST062-31311 CST064-31311 CST070-31311 CST100-31311 CST102-31311

33 CST060-3133 CST062-3133 CST064-3133 CST070-3133 CST100-3133 CST102-3133

CST060-31339 CST062-31339 CST064-31339 CST070-31339 CST100-31339 CST102-31339

CST060-31331 CST062-31331 CST064-31331 CST070-31331 CST100-31331 CST102-31331

34 CST060-3102 CST062-3102 CST064-3102 CST070-3102 CST100-3102 CST102-3102

CST060-31029 CST062-31029 CST064-31029 CST070-31029 CST100-31029 CST102-31029

CST060-31021 CST062-31021 CST064-31021 CST070-31021 CST100-31021 CST102-31021

File Number A17030 Cycle Start Date 22 August 2011 Certificate No. 581.110822 Effective Date 22 August 2011

Expiry Date 02 June 2014

 

Authorised by

Ivor Barrett

Certification Manager For and on Behalf of UL International (UK) Ltd

Notified Body

0843

OBL 00-NB-F0408 1.0