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Hematofix
EUDAMEDClass A (EU MDR)
Ref RWH0012D2 Model Hematology Fixative/Cleaning solution
by Delcon Srl
Identity
- Trade Name
- Hematofix EUDAMED
- Device Name
- Hematofix EUDAMED
- Model / Reference
- Hematology Fixative/Cleaning solution EUDAMEDRWH0012D2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033928530672 EUDAMED
- Basic UDI-DI
- 803392853HEMADQ EUDAMED
- Direct Marketing DI
- 08033928530672 EUDAMED
- EMDN Code
- W0104010804 STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hematofix by Delcon Srl — 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 | 803392853HEMADQ | Class A | Active |
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Manufacturer
- Manufacturer
- Delcon Srl
- EUDAMED SRN
- IT-MF-000014234
Sources (1)
- EUDAMED 4b53514f-7108-45fc-90f4-92891770b241 61 fields · synced Jun 17, 2026