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clinalytix Medical AI
EUDAMEDClass IIa (EU MDR)
Ref clinalytix Medical AIModel clinalytix
Identity
- Trade Name
- clinalytix Medical AI EUDAMED
- Device Name
- clinalytix EUDAMED
- Model / Reference
- clinalytix EUDAMEDclinalytix Medical AI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260693990118 EUDAMED
- Basic UDI-DI
- 426069399CLINALYTIXH4 EUDAMED
- Direct Marketing DI
- 04260693990118 EUDAMED
- EMDN Code
- Z120499 GENERAL MEDICINE INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
clinalytix Medical AI by DH Healthcare GmbH — 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 | 426069399CLINALYTIXH4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- DH Healthcare GmbH
- EUDAMED SRN
- DE-MF-000009069
Sources (1)
- EUDAMED fca1d53b-80c3-48d8-af78-fcd8f442d4dd 61 fields · synced Jun 17, 2026