Identity
- Device Name
- Scanbody EUDAMED
- Model / Reference
- Scanbody EUDAMED21.321.00.000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251923101626 EUDAMED
- Basic UDI-DI
- 425192311931142154259K EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Heliocos GmbH — 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 | 425192311931142154259K | Class I | Active |
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Manufacturer
- Manufacturer
- Heliocos GmbH
- EUDAMED SRN
- DE-MF-000006272
Sources (1)
- EUDAMED 9a5c34af-a972-493e-bf18-788e6814cb03 61 fields · synced Jun 19, 2026