Identity
- Trade Name
- Tribest EUDAMED
- Device Name
- ORTHODONTIC WAX EUDAMED
- Model / Reference
- 81-21251 ~ 81-21300 EUDAMED81-21251 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974815378606 EUDAMED
- Basic UDI-DI
- 69748153781-21251UV EUDAMED
- EMDN Code
- Q01020203 OCCLUSAL WAXES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Tribest by Tribest Dental Products Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69748153781-21251UV | Class I | Active |
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Manufacturer
- Manufacturer
- Tribest Dental Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000027307
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3062c2bd-ff93-4a4b-9d5f-e2ceb5404209 61 fields · synced Jun 17, 2026