Identity
- Device Name
- Dental Bib EUDAMED
- Model / Reference
- DB05, DB06, DB10，DB11 EUDAMEDDB05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975336240540 EUDAMED
- Basic UDI-DI
- 697533624DB001AM EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER 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
Dental Bib by Rocodent International Limited — 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 | 697533624DB001AM | Class I | Active |
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Manufacturer
- Manufacturer
- Rocodent International Limited
- EUDAMED SRN
- CN-MF-000045441
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e8d5d2a1-0fa5-4593-81fd-cbe4c9a9c08b 61 fields · synced Jun 19, 2026