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Biokey Anchorage screw

by BOMEI Co., Ltd 101 variants

Ref CH-2135-0Model CH

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-04719873183609 Basic UDI-DI 04719873183609UDI-DIDate20 Apr 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Non Sterile Orthodontic Anchorage Screw
Model / Reference
CH, CH-2135-0
Primary DI / UDI-DI
04719873183609
Basic UDI-DI
B-04719873183609
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
TW-MF-000013725
Authorised representative
Advena Limited MT-AR-000000234

Other devices from BOMEI Co., Ltd

See all devices from BOMEI Co., Ltd →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No