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Frame with anti-blue light lenses

by Wenzhou Bomin Eyewear Co., Ltd 2 variants

Ref 06978616810150Model BM005

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 Number697868681BM005PS Basic UDI-DI 06978616810150UDI-DIDate8 May 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
BM005, 06978616810150
Primary DI / UDI-DI
06978616810150
Basic UDI-DI
697868681BM005PS
Direct Marketing DI
06978616810150
EMDN Code
Q02100203 Metal and plastic spectacle frames without lenses
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000047575
Authorised representative
Humiss International B.V. NL-AR-000001490

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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