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879A

by Sunoptic International Ltd EUDAMED

Active European Union

Ref 879AModel Frames Metal Mix

Overview

The 879A medical device is a Frames Metal Mix, a device used for implanting metal components into human bodies. It is designed to provide accurate and reliable results in medical procedures. Developed by Sunoptic International Ltd, this device is widely accepted and used across various medical institutions.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50558608fra-met-mixTP Basic UDI-DIDate4 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Frames Metal Mix, 879A
Primary DI / UDI-DI
05055860872163
Basic UDI-DI
50558608fra-met-mixTP
EMDN Code
Q02100201 Metal spectacle frames without lenses
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000009257
Authorised representative
Sunoptic Europe BE-AR-000003314

Other devices from Sunoptic International Ltd

See all devices from Sunoptic International Ltd →

Properties

Show properties
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No