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Reusable Surgical Instrument

by OSTEONIC Co., Ltd. 11 variants

Ref BMA-4518-TAP

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809595975517 Basic UDI-DI 08809595975517UDI-DIDate10 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809595975517 UDI-DI Date21 Jul 2021ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Reusable Surgical Instrument EUDAMED
Genie RCR Instruments GUDID
Generic Name
Bone tap, reusable
Device Name
Surgical Instrument
Model / Reference
BMA-4518-TAP
Primary DI / UDI-DI
08809595975517
Basic UDI-DI
B-08809595975517
FDA Product Code
HWX
EMDN Code
L098003 Orthopaedic and traumatological surgery taps, reusable
GMDN Term
Bone tap, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
KR-MF-000008969
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from OSTEONIC CO., Ltd.

See all devices from OSTEONIC CO., Ltd. →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Serial Number: No
  • Expiration Date: No