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Axiom® MODGS42V

by Etablissements Anthogyr

Ref MODGS42VModel Empty guided surgery kit

Axiom® MODGS42V is a device classified as Class I in the EU and Class II in the US made by Etablissements Anthogyr, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 36633940071QZ) and listed in FDA GUDID since 17 Jan 2024 (UDI-DI 03663394484381), 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 Number36633940071QZ Basic UDI-DI 03663394484381UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03663394484381 UDI-DI Date17 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 36633940071QZ registered 20 May 2026 Active
  • FDA GUDID UDI-DI 03663394484381 listed 17 Jan 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03663394484381
  2. Registered EUDAMED 36633940071QZ

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  • Withdrawn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

Trade name
Integral EUDAMED
Axiom® GUDID
Generic name
Device sterilization/disinfection container, reusable
Model / reference
MODGS42V, Empty guided surgery kit
Primary DI / UDI-DI
03663394484381
Basic UDI-DI
36633940071QZ
FDA product code
KCT
EMDN code
V0599 Clinical procedures kits not included in other classes - other
GMDN term
Device sterilization/disinfection container, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 4.2 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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.

Related devices

Category: Device sterilization/disinfection container, reusable

Similar devices in this category

Other devices filed under CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Etablissements Anthogyr

See all devices from Etablissements Anthogyr →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)