Identity
- Trade Name
- Supreme Endo EUDAMED
- Device Name
- Root Canal Files EUDAMED
- Model / Reference
- TF-123 EUDAMED958104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14062183025198 EUDAMED
- Basic UDI-DI
- B-14062183025198 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE 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
Yes
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
Supreme Endo by CB Healthcare Consulting GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-14062183025198 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CB Healthcare Consulting GmbH
- EUDAMED SRN
- DE-MF-000005902
Sources (1)
- EUDAMED e02a9a0e-ba97-4693-a506-d51ff06ac305 61 fields · synced Oct 6, 2026