Identity
- Trade Name
- CleanLys EUDAMED
- Device Name
- IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER EUDAMED
- Model / Reference
- 20700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 23661562207002 EUDAMED
- Basic UDI-DI
- 3661562ACLEANSOLXXXXXXXKS EUDAMED
- EMDN Code
- W01030399 IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
CleanLys by Diagast — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 3661562ACLEANSOLXXXXXXXKS | Class A | Active |
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Manufacturer
- Manufacturer
- Diagast
- EUDAMED SRN
- FR-MF-000012310
Sources (1)
- EUDAMED 5fda014b-1fe8-4940-8b01-6404eda12247 61 fields · synced Jun 18, 2026