Home/Regulatory

N° 01 — Compliance

Every reference,
clearly routed.

Search approved public IFU files by reference or available UDI-DI. When a document is not loaded for direct download, route the request to the regulatory team for the current controlled file.

Last reviewed: 2026-06-01

N° 02 — MDR Compliance

EU MDR reference point.

Regulation (EU) 2017/745 establishes the EU medical-device framework referenced by this resource page. Product-specific classification, conformity evidence, and processing instructions must be confirmed in the applicable controlled documents.

EU Authorised Representative

AF Pharma Service
Europe SL

Muntaner 281, 5º 1ª
Barcelona 08021 · Spain
Controlled representative record

MDR basis
Article 11
Mandate
Controlled record
Requests
Route through regulatory team
Contact regulatory team

N° 03 — Public IFU Library

Search by reference or UDI-DI.

0 Public IFU files available for direct download
All Approved public files only
UDI-DI Instrument Reference Status IFU
Loading public IFU files… Request an IFU →

N° 04 — Document libraries

Everything else in one place.

RequestBy reference

Technical
Data Sheets

Request the current technical data sheet for a catalogue reference. The controlled TDS library contains 194 current reference-specific files.

Request TDS
RequestVerification

Declarations
of Conformity

Request the applicable controlled declaration for review by the regulatory team.

Request access
RequestAs applicable

Material
Certificates

Request available material documentation for the relevant product reference.

Request certificate
RequestCase review

Audit
Support

Send the required scope and references for regulatory document review.

Request support

Approved public regulatory downloads

These downloads are published with a narrow scope. Use the request route when a product-specific controlled document is required.

Legacy-device confirmation · authorized request

Reusable surgical-instrument scope

Legacy-device transition documentation is held behind regulatory authorization. Request access with the relevant product scope.

Request authorized access
REACH declaration · laryngoscope blades

Miller and Macintosh blades

Product-specific REACH declaration dated 16 September 2025 for the listed laryngoscope-blade scope.

Download REACH declaration
REACH declaration · Pinard stethoscope

Aluminium Pinard stethoscope

Product-specific REACH declaration dated 15 September 2025 for the aluminium Pinard stethoscope.

Download REACH declaration
01

Product-specific processing information

Product-specific processing instructions belong in the applicable controlled IFU. ISO 17664-1:2021 specifies requirements for information manufacturers provide for processing certain medical devices; it does not replace reference-specific instructions.

Review ISO 17664-1:2021
02

Regulatory case routing

Send regulatory questions with the catalogue reference and requested document type. The regulatory team reviews each case and routes available controlled documents for the applicable instrument.

Contact regulatory team

N° 06 — Regulatory questions

Direct answers, bounded by evidence.

These answers describe public website resources and primary regulatory references. Request controlled documents for product-specific determinations.

Last reviewed: 2026-06-01

What can I download from the public IFU library?

The Kopek public IFU library provides approved PDF files for direct download. As of 2026-06-01, the index contains 71 catalogue entries linked to one approved PDF file. Search by reference, available UDI-DI, or instrument name.

#faq-public-ifu-downloads

How do I find an IFU by reference?

Enter the catalogue reference in the public IFU library search field. Matching indexed references display the instrument name, available UDI-DI, status, and a direct PDF download. Request the current controlled file when no approved public PDF is listed.

#faq-find-ifu-reference

Can I search for an IFU by UDI-DI?

Yes. Enter an available UDI-DI in the public IFU library search field. The index searches populated UDI-DI values and catalogue references. Some catalogue entries do not yet display a UDI-DI, so reference-based search remains available.

#faq-search-udi-di

What if an IFU is not publicly listed?

Request the current controlled IFU from the regulatory team when no approved public PDF is listed. Include the catalogue reference and document type. The public library intentionally exposes approved downloads only.

#faq-ifu-not-listed

Are declarations of conformity public downloads?

Declarations of Conformity are routed through the regulatory request form. Submit the relevant catalogue reference so the regulatory team can identify the applicable controlled declaration for review.

#faq-declarations

How do I request a technical data sheet?

Request a technical data sheet through the regulatory form and include the catalogue reference. As of 2026-06-01, the controlled TDS library contains 194 current reference-specific files. Raw TDS files remain request-routed because the regulatory team must identify the applicable revision.

#faq-request-tds

What is a UDI-DI?

A UDI-DI is the device identifier portion of a Unique Device Identifier. The European Commission explains that the MDR introduced a UDI-based identification system to support medical-device traceability.

#faq-udi-di

What is EUDAMED used for?

EUDAMED is the European Commission medical-device database system supporting implementation of the MDR and IVDR. The Commission describes actor registration and UDI/device registration among its modules.

#faq-eudamed

Which regulation is referenced on this page?

This resource page references Regulation (EU) 2017/745 on medical devices, commonly called the EU MDR. Product-specific classification and conformity evidence must be confirmed in the applicable controlled documentation.

#faq-regulation

Does this page confirm every product classification?

No. This resource page does not confirm classification or conformity evidence for every catalogue reference. Request the applicable controlled documentation when a product-specific regulatory determination is required.

#faq-classification

Where are product-specific processing instructions located?

Product-specific processing instructions belong in the applicable controlled IFU. Use the public IFU library when an approved PDF is listed, or request the current controlled IFU for the catalogue reference.

#faq-processing-instructions

What does ISO 17664-1:2021 cover?

ISO 17664-1:2021 specifies requirements for information manufacturers provide for processing certain medical devices. The ISO abstract states that the standard does not define product-specific processing instructions.

#faq-iso-17664

How do I request a material certificate?

Use the regulatory request form and include the relevant product reference. Available material documentation is reviewed and routed by reference so the response matches the requested instrument.

#faq-material-certificate

How do I request regulatory audit support?

Send the audit scope, requested document types, and relevant catalogue references through the regulatory form. The regulatory team can then review the case and route available controlled documents.

#faq-audit-support

When was this regulatory resource page reviewed?

This regulatory resource page was reviewed on 2026-06-01. The review covered public IFU index counts, approved downloadable PDF files, controlled-document request routes, and links to primary regulatory sources.

#faq-last-reviewed

N° 07 — Evidence notes

What this page can support.

Evidence notes separate website observations from primary regulatory references and product-specific controlled documentation.

ISO 13485 quality management system

Supplied controlled certification records support an ISO 13485:2016 quality management system claim.

  • Scope: Manufacturing of laryngoscopes, surgical instruments, and dental instruments.
  • Current valid period: 1 April 2026 to 31 March 2027.
  • Limit: The certification supports the stated QMS scope; it is not a product-specific conformity statement.

Public IFU index

The public index contains 71 catalogue entries linked to one approved PDF file.

  • Method: Counted entries and unique filenames in the deployed IFU data payload.
  • Checked: 2026-06-01.
  • Limit: Catalogue entries are not unique PDF documents.

MDR and EUDAMED

The European Commission describes EUDAMED as a system supporting implementation of the MDR and IVDR.

Processing information

ISO 17664-1:2021 specifies requirements for processing information provided by medical-device manufacturers.

  • Source: ISO 17664-1:2021 abstract.
  • Checked: 2026-06-01.
  • Limit: Use the applicable controlled IFU for product-specific instructions.

EU authorised representative

AF Pharma Service Europe SL is identified in supplied controlled records as Kopek International's EU authorised representative.

  • Route: Regulatory requests are reviewed by the Kopek regulatory team.
  • Record: The representative mandate remains controlled.
  • Limit: Request the applicable controlled record when formal evidence is required.

Legacy-device transition scope

Legacy-device transition documentation is held behind regulatory authorization for its specified reusable surgical-instrument scope.

  • Route: Request authorized access through the regulatory team.
  • Record: The transition document remains controlled.
  • Limit: The document is not a blanket conformity claim for every catalogue item.

Controlled TDS library

The internal TDS library contains 194 current reference-specific files and two archived Pinard revisions.

  • Method: Counted PDFs outside and inside the archive folder.
  • Checked: 2026-06-01.
  • Limit: Current revisions remain available by request, not bulk public download.

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