Identity
- Trade Name
- Tribest EUDAMED
- Device Name
- Prophy Brush and Cup EUDAMED
- Model / Reference
- 15-10001 ~ 15-10050 EUDAMED15-10003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974815370617 EUDAMED
- Basic UDI-DI
- 69748153715-10003RM EUDAMED
- EMDN Code
- Q01010403,Q010502 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 | 69748153715-10003RM | 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 3ffc375d-2794-4915-a634-d50485327fb3 61 fields · synced Jun 18, 2026