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Tls Panier V8

by Fournitures Hospitalieres Industrie

Part of a family of 192 devices: see the family page

Ref 268225

Tls Panier V8 (268225) is a device classified as Class I in the EU and Class II in the US made by Fournitures Hospitalieres Industrie, registered in EUDAMED on 14 Mar 2022 (Basic UDI-DI 3661489PANIERCIAH), cleared under FDA 510(k) K120740 on 5 Mar 2013 (1 earlier submission) and listed in FDA GUDID since 13 Mar 2019 (UDI-DI 03661489682254), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120740

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3661489PANIERCIAH Basic UDI-DI 03661489682254UDI-DIDate14 Mar 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number03661489682254 UDI-DI Date13 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK120740 Date5 Mar 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3661489PANIERCIAH registered 14 Mar 2022 Active
  • FDA 510(k) K120740 decided 5 Mar 2013 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03661489682254 listed 13 Mar 2019 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K113591
  2. Cleared FDA 510(k) K120740
  3. Listed FDA GUDID 03661489682254
  4. Registered EUDAMED 3661489PANIERCIAH

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Tls Panier V8 EUDAMED
Container TLS V8 GUDID
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Trays, Lids, Mats
Model / reference
268225
Primary DI / UDI-DI
03661489682254
Basic UDI-DI
3661489PANIERCIAH
Direct marketing DI
03661489682254
510(k) Number
FDA product code
MBI, HWC
EMDN code
V0499 Clinical use containers (non-IVD) - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 03661489682254: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FR-MF-000000819

Similar devices in this category

Other devices filed under CLINICAL USE CONTAINERS (NON-IVD) - OTHER.

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Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)