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Achsebene-Zeiger mit Fixierschraube

by Amann Girrbach AG

Ref 218610

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberE4942186101 UDI-DI Date22 Aug 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++E494ARTEX7L Basic UDI-DI E4942186101UDI-DIDate6 Oct 2021RegisteredStatusActive

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.

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  • Withdrawn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
Achsebene-Zeiger mit Fixierschraube EUDAMED
accessory GUDID
Generic Name
Facebow
Device Name
jaw relation facebow and accessories / Kieferrelationsbestimmung
Model / Ref / Catalog
218610, Axis plane pointer with screw
Primary DI / UDI-DI
E4942186101
Basic UDI-DI
++E494ARTEX7L
FDA Product Code
KCR
EMDN Code
L15900699 Dental material processing instruments, reusable - other
GMDN Term
Facebow
Device Class
Class I
Regulation Number
872.3220
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
218610
GUDID
Axis plane pointer with screw

Manufacturer details

EUDAMED SRN
AT-MF-000000252

Other devices from Amann Girrbach AG

See all devices from Amann Girrbach AG →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Expiration Date: No
  • Manufacturing Date: No