Identity
- Trade Name
- Documedis CDS.CE EUDAMED
- Device Name
- Documedis CDS.CE EUDAMED
- Model / Reference
- 7649998068024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649998068024 EUDAMED
- Basic UDI-DI
- 7649998068CDSRM EUDAMED
- Direct Marketing DI
- 07649998068024 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
Documedis CDS.CE by HCI Solutions AG — Class IIa — 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 | 7649998068CDSRM | Class IIa | Active |
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Manufacturer
- Manufacturer
- HCI Solutions AG
- EUDAMED SRN
- CH-MF-000044367
- Authorised Representative
- MED-RAS GmbH Regulatory Affairs Service DE-AR-000006211
Sources (1)
- EUDAMED c33b1bd2-5b2c-4b63-b1e4-4ffda28d085f 61 fields · synced Jun 20, 2026