Certifications – Prowa Medical Instruments

Prowa Medical Instruments | Certifications

Accrediations & Certifications

The QA team of Prowa Medical Instruments regularly updates the documentation & policies to make sure that the company comply with the latest international regulations.

ISO 13485 - QMS for Medical Devices

ISO 13485

ISO 9001 - Quality Management

ISO 9001

U.S. Food and Drug Administration (FDA)

US FDA Greenlist

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US FDA Greenlist

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US FDA Greenlist

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US FDA Greenlist

US FDA Greenlisted Products

CE Class I Medical Devices

CE Class I

CE Class IIa & IIb Medical Devices

CE Class IIa & IIb

Health Industry Business Communications Council (HIBCC)

HIBCC LIC

Unique Device Identification (UDI) Codes

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HIBCC LIC

Unique Device Identification (UDI) Codes

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European Database on Medical Devices (EUDAMED)

EUDAMED Actor Information

Economic Operator

EUDAMED Actor Information

Economic Operator

EUDAMED Actor Information

Economic Operator

EUDAMED SRN

Single Registration Number (SRN)

CE Marking

Directive 93/42/EEC

European Authorized Representative (EC REP)

EC REP Certificate

CMC Medical Devices & Drugs S.L., Spain

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EC REP Certificate

CMC Medical Devices & Drugs S.L., Spain

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EC REP Certificate

CMC Medical Devices & Drugs S.L., Spain

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EC REP Certificate

CMC Medical Devices & Drugs S.L., Spain

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EC REP Certificate

CMC Medical Devices & Drugs S.L., Spain

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EC Certificate of Conformity (EU MDR 2017/745)

EC Certificate of Conformity

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EC Certificate of Conformity

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Product / Material

ISO 7151

Surgical instruments — Non-cutting, articulated instruments

ISO 7153-1

Surgical instruments — Materials —
Part 1: Metals

ISO 7741

Scissors and shears — General requirements and test methods

ISO 21850-1

Stainless steels — Dental instruments

ASTM F-899

Wrought stainless steels — Surgical instruments

REACH (EU)

Chemical, material compliance regulation

ISO 14630

Non-active surgical implants — General requirements

ISO 7740

Scalpels with detachable blades — Fitting dimensions

ISO 7376

Laryngoscopes for tracheal intubation

Medical Device Risk Management

ISO 14971

Application of risk management to medical devices

Technically Competent Testing Laboratory

ISO/IEC 17025

Symbols / Manufacturer Information

ISO 15223-1

Symbols to be used with info supplied by manufacturer

ISO 20417

Information to be supplied by the manufacturer

Processing / Sterilization / Sterilized Packaging for Medical Devices

ISO 11607-1

Packaging for terminally sterilized medical devices

ISO 11135

Sterilization of health-care products — Ethylene oxide

ISO 17664

Processing information for medical devices

ISO 17665

Moist heat sterilization

ISO 14937

Sterilization of health-care products

ISO 15883-2

Washer-disinfectors

ISO 13402

Resistance to autoclave, corrosion, thermal exposure

ASTM 380-06

Cleaning, descaling, passivation of stainless steel parts

World Health Organization - Good Manufacturing Practices

WHO GMP

Personal Protective Equipment Regulations (EU) 2016/425

CE Certificate

Occupational Health and Safety (OH&S) Management System

ISO 45001

Environmental Management System

ISO 14001

No Child Labour

No Child Labour

Global Medical Device Nomenclature

GMDN Certificate

Office of District Health Officer Sialkot

Free Sales Certificate

Sialkot Chamber of Commerce & Industry

SCCI Membership Certificate

SCCI Profile Certificate

SCCI Free Sale Certificate

Committee Member

Surgical Instruments Committee

Surgical Instruments Manufacturers Association of Pakistan

SIMAP Membership Certificate

SIMAP Free Sale Certificate

Sialkot Material Testing Laboratory

Analytical Test Report

AISI 420 Grade

Analytical Test Report

AISI 420 Grade

Analytical Test Report

AISI 420 Grade

Company Profile

Company Profile

Intellectual Property Organization of Pakistan

Trademark Registration

Federal Board of Revenue

Tax Payer Registration

Business Activity & NTN

Company Incorporation

Incorporation Certificate

STILL THINKING? LEARN WHY PROWA.ㅤ

CERTIFIED QUALITY /// ETHICAL PRODUCTION STANDARDS /// UDI DATAMATRIX COMPLIANT /// 10,000+ INSTRUMENTS RANGE /// DEDICATED REUSABLE & STERILE RANGE PRODUCTION FACILITIES /// NO QUESTIONS ASKED REPLACEMENT WARRANTY ///

CERTIFIED QUALITY /// ETHICAL PRODUCTION STANDARDS /// UDI DATAMATRIX COMPLIANT /// 10,000+ INSTRUMENTS RANGE /// DEDICATED REUSABLE & STERILE RANGE PRODUCTION FACILITIES /// NO QUESTIONS ASKED REPLACEMENT WARRANTY ///

MADE IN PAKISTAN

manufacturer and exporter of

Surgical and Dental Instruments, Hospital Hollowwares and Furniture, Electrosurgical Instruments, Neuro and Spinal & Maxillofacial Implants, Sterilization Containers and Baskets