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Quantum

by In2Bones SAS 33 variants

Ref M05 10021Model A06 10011

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3701337640927F Basic UDI-DI 03701337602963UDI-DIDate13 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701337602963 UDI-DI Date22 Apr 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Instrument tray, reusable
Model / Ref / Catalog
A06 10011, M05 10021
Primary DI / UDI-DI
03701337602963
Basic UDI-DI
3701337640927F
Direct Marketing DI
03701337602963
510(k) Number
FDA Product Code
FSM
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Instrument tray, reusable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
FR-MF-000005246

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See all devices from In2Bones SAS →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No