Identity
- Trade Name
- OrthosMAIL EUDAMED
- Device Name
- Orthodontic Wires EUDAMED
- Model / Reference
- TF-338 EUDAMED9770096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14062183015465 EUDAMED
- Basic UDI-DI
- B-14062183015465 EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES 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
OrthosMAIL 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-14062183015465 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CB Healthcare Consulting GmbH
- EUDAMED SRN
- DE-MF-000005902
Sources (1)
- EUDAMED 6f29ccfc-7ef7-42ba-bb75-2d2e962b5f57 61 fields · synced Oct 6, 2026