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CoLS universal guide handle V5 264930

by Fournitures Hospitalieres Industrie EUDAMEDGUDID

Active European Union

Ref 264930Model TLS reusable instruments

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3661489LIGTLSCIRMJZ Basic UDI-DIDate4 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number03661489649301 UDI-DIDate13 Mar 2019ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Tls Handle for Guide EUDAMED
CoLS universal guide handle V5 GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Name
TLS reusable instruments
Model / Reference
264930, TLS reusable instruments
Primary DI / UDI-DI
03661489649301
Basic UDI-DI
3661489LIGTLSCIRMJZ
510(k) Number
FDA Product Code
MBI, HWC
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3040
Market of Registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

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Properties

  • Reusable
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No