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Axiom® OPGS36-10

by Etablissements Anthogyr EUDAMEDGUDID

Active European Union

Ref OPGS36-10Model Sleeve

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number36633940091R7 Basic UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03663394485609 UDI-DIDate17 Jan 2024ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Integral EUDAMED
Axiom® GUDID
Generic Name
Dental implant suprastructure, temporary, preformed, reusable
Model / Reference
OPGS36-10, Sleeve
Primary DI / UDI-DI
03663394485609
Basic UDI-DI
36633940091R7
FDA Product Code
NDP
EMDN Code
Q010599 Dental instruments, single-use - other
GMDN Term
Dental implant suprastructure, temporary, preformed, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3980
Market of Registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 4.5 Millimeter
Outer Diameter — 5.8 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

Other devices from Etablissements Anthogyr

See all devices from Etablissements Anthogyr →

Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: 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
  • Serial Number: No
  • Expiration Date: No