Identity
- Trade Name
- SELEXION digital EUDAMED
- Device Name
- Zirlux Disc Aman Girrbach EUDAMED
- Model / Reference
- TF-054 EUDAMED957669 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04062183003212 EUDAMED
- Basic UDI-DI
- B-04062183003212 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental appliance fabrication material, ceramic
SELEXION digital by CB Healthcare Consulting GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04062183003212 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CB Healthcare Consulting GmbH
- EUDAMED SRN
- DE-MF-000005902
Sources (1)
- EUDAMED b97e1973-e563-4531-9321-0109d4a58a51 61 fields · synced Jul 25, 2026