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Fecal Occult Blood (FOB) Test Kit (LIA)
EUDAMEDClass IVD General (EU MDR)
Ref BQX1Model Hitachi 7020, 7180, Beckman AU680,OC-Sensor IO
Identity
- Trade Name
- Fecal Occult Blood (FOB) Test Kit (LIA) EUDAMED
- Device Name
- Fecal Occult Blood (FOB) Test Kit (LIA) EUDAMED
- Model / Reference
- BQX1 EUDAMEDHitachi 7020, 7180, Beckman AU680,OC-Sensor IO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975867980021 EUDAMED06975867980007 EUDAMED
- Basic UDI-DI
- B-06975867980021 EUDAMED695786798BQX01XK EUDAMED
- Direct Marketing DI
- 06975867980007 EUDAMED
- EMDN Code
- W0103010201 HAEMOGLOBIN DETERMINATIONS (TOTAL HB) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Fecal Occult Blood (FOB) Test Kit (LIA) by Hunan Hehao Medical Technology Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED
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 | B-06975867980021 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hunan Hehao Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000029298
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 4c7d0bed-ec3c-4b2b-8ac7-79fb8bf0ca50 61 fields · synced Oct 6, 2026
- EUDAMED a2febc91-79ce-43e6-a536-135b035853dc 61 fields · synced May 19, 2026