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DuaFit®

by In2Bones SAS 4 variants

Part of a family of 21 devices: see the family page

Ref A06 10011

DuaFit® (A06 10011) is a Class I device made by In2Bones SAS, registered in EUDAMED on 13 Apr 2026 (Basic UDI-DI 3701337640927F) and listed in FDA GUDID since 9 May 2022 (UDI-DI 03760225710913), 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 Number3701337640927F Basic UDI-DI 03760225710913UDI-DIDate13 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760225710913 UDI-DI Date9 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3701337640927F registered 13 Apr 2026 Active
  • FDA GUDID UDI-DI 03760225710913 listed 9 May 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760225710913
  2. Registered EUDAMED 3701337640927F

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  • Withdrawn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
Primary DI / UDI-DI
03760225710913
Basic UDI-DI
3701337640927F
Direct marketing DI
03760225710913
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 registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)