Zirlux
by Henry Schein Inc. United States EUDAMED
Ref 9012998Model TF-054 (ZI)
EMDN Q01010199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-00304040156155 | Date28 May 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
EU market availability
Available in 12 countries, as listed in EUDAMED:
- Czechiasince 28 Jul 1997
- Denmarksince 28 Jul 1997
- Francesince 28 Jul 1997
- Germanysince 28 Jul 1997
- Italysince 28 Jul 1997
- Netherlandssince 28 Jul 1997
- Northern Irelandsince 28 Jul 1997
- Norwaysince 28 Jul 1997
- Polandsince 28 Jul 1997
- Portugalsince 28 Jul 1997
- Spainsince 28 Jul 1997
- Swedensince 28 Jul 1997
Specification
- Device Name
- Zirlux Disc Aman Girrbach
- Model / Reference
- TF-054 (ZI), 9012998
- Primary DI / UDI-DI
- 00304040156155
- Basic UDI-DI
- B-00304040156155
- EMDN Code
- Q01010199 Dental restoration devices - other
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000021683
- Authorised representative
- Henry Schein Services GmbH DE-AR-000008001
Other devices from Henry Schein, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- 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
Sources (1)
- EUDAMED 00304040156155|B-00304040156155