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CERTIFICATES

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Name.

ISO 13485 : 2016

No.

TC-75340

Reference.

This certificate shows that the medical device - quality management syetem (EN ISO 13485:2016) of the above company was approved by PCA Certification for the following scope, the validity of the certificate depends on th company's pass the annual survellance audits and company's maintenance the related management system conditions according to international accerditation criteria.

Name.

ISO 9001:2015

No.

01.20.8815.114469.D

Reference.

To certify that Quality Management System in accordance with standard's clauses is established and being implemented.

Name.

CE marking

No.

254235-2020

Reference.

1) had drawn CE Declaration of Conformity in compliance with Annex-VII of Council Directive 93/42-EEC.
2) has established and maintaining technical documentation of class-1 Surgical & Dental Instruments in compliance with Annex-VII of Council Directive 93/42-EEC.
3) has designated their Authorized Representivate in the European Community in compliance with Article 14(2) of Council Directive 93/42-EEC.

Name.

The Surgical Instruments Manufacturers Assosiation of Pakistan

No.

A020

Reference.

Membership Certificate

Name.

The Sialkot Chamber of commerce & Industry

No.

C-0125

Reference.

Membership Certificate

Name.

Department Of Health & Human Services

Reference.

Department Of Health & Human Services

Name.

GMP

Reference.

GMP

Name.

Free Sales Certificate

No.

653

Reference.

It is certified thad Surgical Dental & Medical Instruments, Manufactured by M/S A-One Surgico (Pvt) Ltd. Muhammad Pura, Sialkot-51310 Pakistan. are Hygienically Acceptable and this firm freely sells these Instruments in Pakistan as well as abroad.

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