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VERSALOOP™ 1.5mm Disposable Drill

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

Ref 514001mModel Versaloop System-Orthopaedic Surgical Drills

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
European UnionCE/MDR EUDAMED Number81012846VERSALOOPORTHJ7 Basic UDI-DI 10818674024973UDI-DIDate22 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number10818674024973 UDI-DI Date3 Dec 2020ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Cannulated surgical drill bit, single-use
Model / Ref / Catalog
Versaloop System-Orthopaedic Surgical Drills, 514001m, 210199
Primary DI / UDI-DI
10818674024973
Basic UDI-DI
81012846VERSALOOPORTHJ7
Direct Marketing DI
10818674024973
FDA Product Code
HTO
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
Versaloop System-Orthopaedic Surgical Drills
514001m
GUDID
210199
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