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Fecal Occult Blood Rapid Test Device
EUDAMEDClass IVD General (EU MDR)
Ref FS05-101-1Model FS05-101
Identity
- Trade Name
- Fecal Occult Blood Rapid Test Device EUDAMED
- Device Name
- Fecal Occult Blood Rapid Test Device EUDAMED
- Model / Reference
- FS05-101 EUDAMEDFS05-101-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975519631063 EUDAMED
- Basic UDI-DI
- B-16975519631063 EUDAMED
- EMDN Code
- W0101060301 GUAIAC-BASED FAECAL OCCULT BLOOD (CC) 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Fecal Occult Blood Rapid Test Device by Hangzhou Bosure Biotech 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-16975519631063 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bosure Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000003001
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED fe99a18d-e88e-4bec-87e2-2e47ae06f4b9 61 fields · synced Jul 9, 2026