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Fecal Occult Blood (FOB) Detection Kit (Immunofluorescence Chromatography
EUDAMEDClass IVD General (EU MDR)
Ref GKPD180
Identity
- Trade Name
- Fecal Occult Blood (FOB) Detection Kit (Immunofluorescence Chromatography EUDAMED
- Device Name
- Fecal Occult Blood (FOB) Detection Kit (Immunofluorescence Chromatography EUDAMED
- Model / Reference
- GKPD180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GKPD180XN EUDAMED
- Basic UDI-DI
- B-GKPD180XN EUDAMED
- EMDN Code
- W0102160203 FECAL OCCULT BLOOD - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General 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
Fecal Occult Blood (FOB) Detection Kit (Immunofluorescence Chromatography by Dezhou Guoke Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in…
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-GKPD180XN | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 949181e3-2597-495a-a4b3-7f1f8921a36e 61 fields · synced Jun 19, 2026