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MK48B

by Sunoptic International Ltd

Ref MK48BModel Frames Metal Mix

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50558608fra-met-mixTP Basic UDI-DI 05055860896947UDI-DIDate4 Dec 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Frames Metal Mix
Model / Reference
Frames Metal Mix, MK48B
Primary DI / UDI-DI
05055860896947
Basic UDI-DI
50558608fra-met-mixTP
EMDN Code
Q0210030101 Ready to wear metal spectacles with organic lenses
Device Class
Class I
EU 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

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