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Betta Link Disposable Soft Bone Drill Bit

by T.A.G. Medical products corporation LTD. 3 variants

Ref 183200bsmModel Betta Link™ Knotless Anchor System

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

CE MDR

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
United StatesGUDID listing GUDID Number10818674028803 UDI-DI Date31 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number81012846BettaLinkORTHW8 Basic UDI-DI 10818674028803UDI-DIDate29 Dec 2024RegisteredStatusActive

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Cannulated surgical drill bit, single-use
Device Name
Betta Link Disposable Hard Bone Drill Bit
Model / Ref / Catalog
Betta Link™ Knotless Anchor System, 183200bsm, 110045153
Primary DI / UDI-DI
10818674028803
Basic UDI-DI
81012846BettaLinkORTHW8
Direct Marketing DI
10818674028803
FDA Product Code
HTW
EMDN Code
Z12130503 Orthopaedic surgical drills
GMDN Term
Cannulated surgical drill bit, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Betta Link™ Knotless Anchor System
183200bsm
GUDID
110045153
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IL-MF-000029151
Authorised representative
MedNet EC-REP IIb GmbH DE-AR-000011192

Other devices from T.A.G. Medical products corporation LTD.

See all devices from T.A.G. Medical products corporation LTD. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No