8/17/2019 CE Certificate.pdf

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File Number A17801 Cycle Start Date 12 April 2013Certificate No. 621.130607 Effective Date 07 June 2013

Expiry Date 11 April 2016

Authorised by

Ms Anwen E EvansCertification Manager

For and on Behalf of UL International (UK) Ltd 

Notified Body

0843  00-NB-F0413 2.0 

Perfint Healthcare Pvt. Ltd.3rd Floor, No.16, South West Boag Road, T.Nagar, Chennai, TamilNadu – 600017,India 

Full Quality Assurance SystemApproval CertificateAnnex II, section 3 of Council Directive 93/42/EEC concerning medical devices 

Scope of Certificate:The design, development, manufacturing, servicing of installation of Robotic devicesand Planning system for soft tissue intervention

Device Classification:Class IIa

Device Descriptions:Planning and Robotic Targeting System for Image Guided interventional procedures

Model Type:Please see Attachment 1of 1

We hereby declare that an examination of the full quality assurance system has been carried out per report

13CA16294 , 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 (1) attachment listing models. 

8/17/2019 CE Certificate.pdf

2/2

 

File Number A17801 Cycle Start Date 12 April 2013Certificate No. 621.130607 Effective Date 07 June 2013

Expiry Date 11 April 2016

Authorised by

Ms Anwen E EvansCertification Manager

For and on Behalf of UL International (UK) Ltd 

Notified Body

0843  00-NB-F0413 2.0 

Perfint Healthcare Pvt. Ltd.3rd Floor, No.16, South West Boag Road, T.Nagar, Chennai, TamilNadu – 600017,

India 

Attachment 1 of 1 

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

Product Family Product Sub-Group Model/Type Classification

Needle Positioners PIGA CT V2P Class IIa

PIGA CT ROBIO EX Class IIa

Image Guided Robotic

Devices

MAXIO V1 Class IIa

MAXIO V2 Class IIa

Procedure Planning System NAVIOS  V1  Class IIa