Identity
- Trade Name
- CX-Prime EUDAMED
- Device Name
- CX-Prime EUDAMED
- Model / Reference
- SW000XXX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251823900015 EUDAMED
- Basic UDI-DI
- 4251823900018C EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software 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
CX-Prime by caresyntax 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 | 4251823900018C | Class I | Active |
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Manufacturer
- Manufacturer
- caresyntax GmbH
- EUDAMED SRN
- DE-MF-000006861
Sources (1)
- EUDAMED f820675e-bcd0-4762-9804-84460e3521ce 61 fields · synced Jul 17, 2026