← Back to catalogue
Soluzione HEMOfast - 1 Lt
EUDAMEDClass A (EU MDR)
Ref CYR000012Model Soluzione HEMOfast
Identity
- Trade Name
- Soluzione HEMOfast - 1 Lt EUDAMED
- Device Name
- Soluzione HEMOfast EUDAMED
- Model / Reference
- Soluzione HEMOfast EUDAMEDCYR000012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050999100306 EUDAMED
- Basic UDI-DI
- 805099910CYR006EL EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER 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
Soluzione HEMOfast - 1 Lt by Hospitex International S.r.l. — 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 | 805099910CYR006EL | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hospitex International S.r.l.
- EUDAMED SRN
- IT-MF-000041985
Sources (1)
- EUDAMED c59e44ef-b002-4f8d-8bfd-3f32a9dec483 61 fields · synced Jun 19, 2026