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Quantum

by In2Bones SAS 57 variants

Part of a family of 60 devices: see the family page

Ref M05 00155Model M05 00143

Quantum (M05 00155) is a device classified as Class IIa in the EU and Class I in the US made by In2Bones SAS, registered in EUDAMED on 9 Dec 2025 (Basic UDI-DI 3701337619197V) and listed in FDA GUDID since 13 Dec 2024 (UDI-DI 03701337613617), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3701337619197V Basic UDI-DI 03701337613617UDI-DIDate9 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number03701337613617 UDI-DI Date13 Dec 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3701337619197V registered 9 Dec 2025 Active
  • FDA GUDID UDI-DI 03701337613617 listed 13 Dec 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03701337613617
  2. Registered EUDAMED 3701337619197V

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  • Withdrawn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
Surgical implant template, reusable
Model / Ref / Catalog
M05 00143, M05 00155
Primary DI / UDI-DI
03701337613617
Basic UDI-DI
3701337619197V
FDA product code
HWT
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical implant template, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4800
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
FR-MF-000005246

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from In2Bones SAS

See all devices from In2Bones SAS →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)