Certifications

Certifications and registrations.

Polymatech manufactures to recognised international and Indian standards. Copies of certificates and registrations are shared with customers on request.

Management systems

ISO 13485:2016

Quality management for medical devices

ISO 9001:2015

Quality management

ISO 14001:2015

Environmental management

ISO 45001:2018

Occupational health and safety

Certified for the manufacture of medical devices such as the Vein Finder at Oragadam, Tamil Nadu.

Vein Finder registrations

United States

FDA Registered Establishment and Device Listed, Class I, 510(k)-Exempt. Registration and listing do not denote FDA approval or clearance.

India

CDSCO Class A medical-device registration.

European Union

CE marking under the Low Voltage Directive 2014/35/EU. Not evidence of conformity under the EU Medical Device Regulation.

Bureau of Indian Standards

BIS licences for LED luminaires and LED controlgear manufactured by Polymatech. These cover the finished lighting products, not bare CoB chips.

Copies of certificates, registrations and licences are available to customers on request: sales@polymatechworld.com.

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Tell us the product, the application and the quantity you need. Polymatech will direct your enquiry to the responsible team.

Polymatech Electronics Limited
Oragadam, Tamil Nadu, India.

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or email sales@polymatechworld.com

Plot No. OZ-13, SIPCOT Hi-Tech SEZ, Oragadam, Tamil Nadu 602 105, India