Identity
- Trade Name
- Scanbody EUDAMED
- Device Name
- CAD-SBBBLB0 EUDAMED
- Model / Reference
- CAD-SBBBLB0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640169731662 EUDAMED
- Basic UDI-DI
- 0764016973CADSBVV EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Scanbody by Biodenta Swiss AG — 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 | 0764016973CADSBVV | Class I | Active |
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Manufacturer
- Manufacturer
- Biodenta Swiss AG
- EUDAMED SRN
- CH-MF-000034374
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED c9dbd963-4f8d-418f-94b0-d872b5643d9d 61 fields · synced Jun 19, 2026