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FOB/TRF/HP Rapid Test Cassette(Colloidal Gold
EUDAMEDClass IVD General (EU MDR)
Ref GKPD038Model 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box
Identity
- Trade Name
- FOB/TRF/HP Rapid Test Cassette(Colloidal Gold EUDAMED
- Device Name
- FOB/TRF/HP Rapid Test Cassette(Colloidal Gold EUDAMED
- Model / Reference
- 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box EUDAMEDGKPD038 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698402062 EUDAMED
- Basic UDI-DI
- B-06977698402062 EUDAMED
- EMDN Code
- W0105010401 H. PYLORI ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
FOB/TRF/HP Rapid Test Cassette(Colloidal Gold by Dezhou Guoke Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06977698402062 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 274c574a-b1f4-4ed5-86f4-4ba7eaf69264 61 fields · synced Oct 6, 2026