← Back to catalogue
Fecal Occult Blood (FOB) Test Kit (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref BB0102Model Cassette type: 50 pcs/boxRef BB0103Model Cassette type: 100 pcs/box
Identity
- Trade Name
- Fecal Occult Blood (FOB) Test Kit (Colloidal Gold) EUDAMED
- Device Name
- Fecal Occult Blood (FOB) Test Kit (Colloidal Gold) EUDAMED
- Model / Reference
- Cassette type: 50 pcs/box EUDAMEDBB0102 EUDAMEDCassette type: 100 pcs/box EUDAMEDBB0103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970522640227 EUDAMED06970522640234 EUDAMED
- Basic UDI-DI
- B-06970522640227 EUDAMEDB-06970522640234 EUDAMED
- EMDN Code
- W0103010299 OTHER HAEMOGLOBIN (TYPES) TESTING - 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
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
Fecal Occult Blood (FOB) Test Kit (Colloidal Gold) by Sichuan Orienter Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06970522640227 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 0cffa7ef-919c-4442-9941-dea50de209d3 61 fields · synced Oct 6, 2026
- EUDAMED 902b9b08-38e8-4a5a-b40e-2a8ec6816f57 61 fields · synced May 18, 2026