Identity
- Trade Name
- FIT Hemoglobin AA01 EUDAMED
- Device Name
- FIT Hemoglobin AA01 EUDAMED
- Model / Reference
- 913935 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987274139352 EUDAMED
- Basic UDI-DI
- 4987274W0102039013HBR02YB EUDAMED
- EMDN Code
- W0102039013 FECAL OCCULT BLOOD (IC) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
FIT Hemoglobin AA01 by Alfresa Pharma Corporation — Class C — 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 | 4987274W0102039013HBR02YB | Class C | Active |
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Manufacturer
- Manufacturer
- Alfresa Pharma Corporation
- EUDAMED SRN
- JP-MF-000008778
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c10a3da9-c45a-411e-8461-a0592c74d865 61 fields · synced Jul 8, 2026