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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.
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.
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.
The Surgical Instruments Manufacturers Assosiation of Pakistan
No.A020
Reference.Membership Certificate
The Sialkot Chamber of commerce & Industry
No.C-0125
Reference.Membership Certificate
Department Of Health & Human Services
Reference.Department Of Health & Human Services
GMP
Reference.GMP
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.
