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Neosys

by In2Bones SAS 8 variants

Ref G02 10081

Neosys (G02 10081) is a device classified as Class IIa in the EU and Class I in the US made by In2Bones SAS, registered in EUDAMED on 24 Apr 2026 (Basic UDI-DI B-03701337606152) and listed in FDA GUDID since 13 Dec 2024 (UDI-DI 03701337606152), active as of 25 Oct 2026.

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

CE MDD

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03701337606152 Basic UDI-DI 03701337606152UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701337606152 UDI-DI Date13 Dec 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03701337606152 registered 24 Apr 2026 Active
  • FDA GUDID UDI-DI 03701337606152 listed 13 Dec 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03701337606152
  2. Registered EUDAMED B-03701337606152

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Orthopaedic surgical procedure kit, non-medicated, single-use
Device name
Neosys Single Use Intruments Set
Model / Ref / Catalog
G02 10081
Primary DI / UDI-DI
03701337606152
Basic UDI-DI
B-03701337606152
FDA product code
KDD
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

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

Related devices

Category: Joint prosthesis implantation kit, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from In2Bones SAS

See all devices from In2Bones SAS →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)