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Betta Link SR Reusable Obturator

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

Ref 184100bsmModel Betta Link™ Knotless Anchor System Reusable Instruments

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 Number10818674028865 UDI-DI Date31 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number81012846BettaLinkREGW Basic UDI-DI 10818674028865UDI-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  • Withdrawn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

Trade Name
Betta Link SR Reusable Obturator EUDAMED
Betta Link Reusable Obturator GUDID
Generic Name
Arthroscopic obturator
Device Name
Betta Link SR Reusable Pronged Guide
Model / Ref / Catalog
Betta Link™ Knotless Anchor System Reusable Instruments, 184100bsm, 110045218
Primary DI / UDI-DI
10818674028865
Basic UDI-DI
81012846BettaLinkREGW
Direct Marketing DI
10818674028865
FDA Product Code
LXH
EMDN Code
L0299 Suture instruments, reusable - other
GMDN Term
Arthroscopic obturator
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Betta Link™ Knotless Anchor System Reusable Instruments
184100bsm
GUDID
110045218

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

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

Other properties (20)

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