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Zirlux 9012310

by Henry Schein, Inc.

Ref 9012310Model TF-054 (ZI)

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

CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00304040056110 Basic UDI-DI 00304040056110UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00304040056110 UDI-DI Date31 May 2017ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Zirlux
Generic Name
Dental appliance fabrication material, ceramic
Device Name
Zirlux Disc Aman Girrbach
Model / Ref / Catalog
9012310, TF-054 (ZI)
Primary DI / UDI-DI
00304040056110
Basic UDI-DI
B-00304040056110
FDA Product Code
EIH
EMDN Code
Q01010199 Dental restoration devices - other
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.6660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Outer Diameter — 98.5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: 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
  • Premarket Exempt: No