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FOB Rapid Test
EUDAMEDClass B (EU MDR)
Ref TFO-N602Ref TFO-N602B-25Ref TFO-N602B-20
Identity
- Trade Name
- FOB Rapid Test EUDAMED
- Device Name
- FOB Rapid Test EUDAMED
- Model / Reference
- TFO-N602 EUDAMEDTFO-N602B-25 EUDAMEDTFO-N602B-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983104425 EUDAMED06936983109437 EUDAMED06936983109420 EUDAMED06936983104418 EUDAMED
- Basic UDI-DI
- 6970277510000BXD EUDAMED
- EMDN Code
- W0101060301 GUAIAC-BASED FAECAL OCCULT BLOOD (CC) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
FOB Rapid Test by Hangzhou Alltest Biotech.Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6970277510000BXD | Class B | 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 (4)
- EUDAMED 98d27317-0db6-47cd-8f9f-b26e6ee18ef6 61 fields · synced Jul 19, 2026
- EUDAMED 44137361-9374-46f3-a2bb-58711629c3c5 61 fields · synced May 17, 2026
- EUDAMED 2704f513-474f-403f-b55d-69fdc8c4091e 61 fields · synced May 18, 2026
- EUDAMED ca28c722-b91b-4e7b-90fd-4f129bae8bf2 61 fields · synced May 19, 2026