← Back to catalogue
Human Fecal Occult Blood (FOB) Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref Human Fecal Occult Blood (FOB) Rapid Test Kit
Identity
- Device Name
- Human Fecal Occult Blood (FOB) Rapid Test Kit EUDAMED
- Model / Reference
- Human Fecal Occult Blood (FOB) Rapid Test Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975445472115 EUDAMED
- Basic UDI-DI
- B-06975445472115 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Human Fecal Occult Blood (FOB) Rapid Test Kit by Farmasino Medical Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975445472115 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Farmasino Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000026190
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 727ece8c-734f-4681-a0a7-3cb8d8b6ff78 61 fields · synced Jun 19, 2026