Identity
- Trade Name
- clinalytix EUDAMEDclinalytix Medical AI EUDAMED
- Device Name
- clinalytix EUDAMED
- Model / Reference
- clinalytix EUDAMEDclinalytix Medical AI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260693990095 EUDAMED04260693990033 EUDAMED04260693990149 EUDAMED
- Basic UDI-DI
- 426069399CLINALYTIXH4 EUDAMED
- Direct Marketing DI
- 04260693990095 EUDAMED04260693990033 EUDAMED04260693990149 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 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 (3)
- EUDAMED 91fa1536-4db6-44f6-8823-aa60fd3c6ee8 61 fields · synced Jul 15, 2026
- EUDAMED 5c38de9e-8a66-490a-9b98-dffcb0613b79 61 fields · synced May 16, 2026
- EUDAMED 8838dcd5-7b20-4ace-9e5b-309b162f7153 61 fields · synced May 19, 2026