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Axiom OPIA100

by Etablissements Anthogyr

Ref OPIA100Model Implant analog

Axiom OPIA100 is a Class I device made by Etablissements Anthogyr, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 36633940113QQ) and listed in FDA GUDID since 23 Nov 2023 (UDI-DI 03663394006897), 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 Number36633940113QQ Basic UDI-DI 03663394006897UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03663394006897 UDI-DI Date23 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 36633940113QQ registered 20 May 2026 Active
  • FDA GUDID UDI-DI 03663394006897 listed 23 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03663394006897
  2. Registered EUDAMED 36633940113QQ

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  • Withdrawn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
Axiom
Generic name
Dental implant analog
Model / Ref / Catalog
OPIA100, Implant analog
Primary DI / UDI-DI
03663394006897
Basic UDI-DI
36633940113QQ
FDA product code
NDP
EMDN code
Q010207 Dental impression devices for prosthetic dentistry
GMDN term
Dental implant analog
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 03663394006897: EUDAMED states No, FDA GUDID states Yes.

Related devices

Category: Dental implant analog

Similar devices in this category

Other devices filed under DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY.

Other devices from Etablissements Anthogyr

See all devices from Etablissements Anthogyr →

Properties

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