Skip to content

OBS Anchorage screw

by BOMEI Co., Ltd 15 variants

Ref BD-2102-0Model BD

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152297↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719873180264 Basic UDI-DI 04719873180264UDI-DIDate20 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04719873180264 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK152297 Date9 Feb 2016IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Orthodontic anchoring screw
Device Name
Non Sterile Orthodontic Anchorage Screw
Model / Ref / Catalog
BD, BD-2102-0
Primary DI / UDI-DI
04719873180264
Basic UDI-DI
B-04719873180264
FDA Product Code
OAT
EMDN Code
Q010499 Orthodontic devices - other
GMDN Term
Orthodontic anchoring screw
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3640
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (17)

  • Sterile: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No