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One Step Fecal Occult Blood (FOB)Test
EUDAMEDFDA 510(k)Class IVD devices for self-testing (EU MDR)
Ref W030-S(50ng/ml)Ref W030-C(50ng/ml)
Identity
- Device Name
- One Step Fecal Occult Blood (FOB)Test EUDAMED
- Model / Reference
- W030-S(50ng/ml) EUDAMEDW030-C(50ng/ml) EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-W030-S(50ng/ml)HE EUDAMEDD-W030-C(50ng/ml)2W EUDAMED
- Basic UDI-DI
- B-W030-S(50ng/ml)HE EUDAMEDB-W030-C(50ng/ml)2W EUDAMED
- EMDN Code
- W0102160203 FECAL OCCULT BLOOD - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
One Step Fecal Occult Blood (FOB)Test by Guangzhou Wondfo Biotech Co., Ltd. — Class IVD devices for self-testing — FDA_510K, IVDD — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162333 | Class IVD devices for self-testing | Active |
| EUDAMED | European Union | CE/IVDD | B-W030-S(50ng/ml)HE | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000000689
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED c864540d-ea29-4c80-89c5-0d1c3bcdb299 61 fields · synced Jul 11, 2026
- EUDAMED e4c459f9-0735-4872-b416-9fe6a2bb2a0e 61 fields · synced Jul 11, 2026
- FDA 510(k) K162333 1 fields · synced May 18, 2026