Identity
- Trade Name
- OrthosMAIL EUDAMED
- Device Name
- Orthodontic Elastics EUDAMED
- Model / Reference
- TF-337 EUDAMED9770077 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14062183015274 EUDAMED
- Basic UDI-DI
- B-14062183015274 EUDAMED
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS 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
Category: Orthodontic retainer
OrthosMAIL by CB Healthcare Consulting GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic retainer.
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- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Stainless Steel Spring — American Orthodontics · Class IIa
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-14062183015274 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CB Healthcare Consulting GmbH
- EUDAMED SRN
- DE-MF-000005902
Sources (1)
- EUDAMED 6fb85689-b251-4234-bc71-b97621335648 61 fields · synced Jun 18, 2026