Our Certificates
Grey Medical documentation
Our certificates.
Quality-management, conformity and representative records for the stated product scope.
Quality in practice
Built around care, craftsmanship and documented processes.
Grey Medical is an international surgical-instrument manufacturer and supply partner. Our production unit in Sialkot, Pakistan brings together skilled manufacturing teams, careful material selection, precision finishing, final inspection and export-ready preparation.
Documentation library
Quality, conformity and representative records.
The documents below are supplied for reference. Please open the original document to review its full certificate number, scope, validity period and issuer information.
ISO 13485:2016
Quality Management System for Medical Devices covering manufacturing and exporting of surgical, dental and orthopaedic instruments.
- Certificate: 3050260411118MD
- Certification date: 11 April 2026
- Expiry shown: 10 April 2029
EU Representative Certificate
Certificate of registration describing an EU representative arrangement for the stated Class I medical-device scope.
- Certificate: IBC 02604161A
- Issue date: 16 April 2026
- Expiry shown: 15 April 2027
EU Declaration of Conformity
Declaration of conformity covering the named product categories and regulatory references stated in the document.
- Document date: 2 August 2024
- Representative: KB International
- Reference: EU MDR 2017/745
EU Authorised Representative Registration
Registration document for the named authorised representative and product category. Its displayed validity period has ended.
- Registration: EAR/PK/7259
- AR start shown: 2 August 2025
- AR end shown: 1 August 2026
ECM MDR Confirmation Letter
Four-page confirmation letter under Regulation (EU) 2023/607 for the legacy-device framework described in the letter.
- Reference: 155/F
- Letter date: 26 September 2024
- Format: PDF, 4 pages
Important document notice
Certificates and declarations are subject to their stated scope, terms and validity dates. They do not replace product-specific regulatory documentation or issuer verification. Please check the original document and contact Grey Medical before relying on a document for a particular product, territory or order.
Certificate verification
Everything you need to review a document.
Use the original certificate files above to check the certificate number, stated scope, issuing organisation and displayed validity dates. For a product-specific request, send the product reference and destination market to Grey Medical.
Open the Original Document
Certificates are provided in their original document format so you can review the complete scope, reference number, dates and issuer information.
View certificate library ↓ISO 13485:2016
Review the ISO certificate for the stated Quality Management System scope covering medical-device manufacturing and exporting.
Open ISO certificate ↗Representative & Declaration
Review the EU Representative Certificate and EU Declaration of Conformity for the categories and references stated in each document.
Open declaration ↗Request the Right Document
Share your product name or reference, intended use and destination country for help locating the appropriate available documentation.
Email documentation team ↗Need product-specific documents?
Tell us the product and destination market.
For the most relevant available documentation, share the product name or reference, intended use and destination country with the Grey Medical team.
Frequently asked questions
Certificates & documentation FAQs.
Quick answers about the documents displayed here and how to request the right information for a product.
Which certificates are available on this page?
The page includes the displayed ISO 13485 certificate, EU representative records, an EU Declaration of Conformity and an ECM MDR confirmation letter.
Does ISO 13485 apply to every Grey Medical product?
The certificate has a stated scope. Review the original certificate and request product-specific documentation before relying on it for a particular item.
How can I verify a certificate?
Use the certificate number and issuer details printed on the original document. You may also contact Grey Medical for help identifying the document relevant to your enquiry.
Is an EU representative certificate the same as product approval?
No. A representative record does not by itself confirm that every product is approved for every market. Product classification, intended use and local rules should be checked separately.
Can these documents be used in every country?
Requirements differ by market. Check the relevant product documentation and local requirements for the country where the product will be supplied or used.
What does the EU Declaration of Conformity cover?
The declaration covers the products, standards and regulatory references stated in that document. Open the original file to review its full scope and document date.
Are the certificates displayed here current?
Each card displays the date or expiry information visible on its source document. Always review the original file and confirm current status with the issuer when required.
Why is one document marked as a reference document?
The registration document is marked as a reference because its displayed validity period has ended. It is kept for transparency and should not be presented as current without an updated record.
Can I request a product-specific declaration or certificate?
Yes. Email [email protected] with the product name or reference, destination market and intended use so the team can guide you to the appropriate available documentation.
Where are Grey Medical instruments produced?
Grey Medical's production unit and export desk are in Sialkot, Pakistan, supported by customer-support offices in the United Kingdom, France and Australia.
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