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FOB Rapid Test Cassette
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref TFO-602HRef TFO-R602QRef TFO-602
Identity
- Trade Name
- FOB Rapid Test Cassette EUDAMED
- Device Name
- FOB Rapid Test Cassette EUDAMED
- Model / Reference
- TFO-602H EUDAMEDTFO-R602Q EUDAMEDTFO-602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983129473 EUDAMED06936983188777 EUDAMED06970277512411 EUDAMED
- Basic UDI-DI
- B-06936983129473 EUDAMEDB-06936983188777 EUDAMEDB-06970277512411 EUDAMED
- EMDN Code
- W0101060301 GUAIAC-BASED FAECAL OCCULT BLOOD (CC) EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDIreland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
FOB Rapid Test Cassette by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD devices for self-testing — 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-06936983129473 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED b3401e70-a425-4948-85e9-cf04a0d33cec 61 fields · synced Jul 31, 2026
- EUDAMED 62aa150a-5461-44f3-b7c3-9e96c745bf4d 61 fields · synced May 17, 2026
- EUDAMED aa8e0893-96ee-404f-951e-26f29694fcda 61 fields · synced May 18, 2026