Identity
- Trade Name
- Tribest EUDAMED
- Device Name
- Medical Surgical face masks EUDAMED
- Model / Reference
- 11-70006 ~ 11-70030 EUDAMED11-70006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974815370709 EUDAMED
- Basic UDI-DI
- 69748153711-70006RR EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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 | 69748153711-70006RR | 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 e0d2d106-e44d-4526-b430-ee656d03ec63 61 fields · synced Jun 19, 2026