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Pregnancy(HCG)Rapid TestCassette(Coloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref GKPD026Model 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box
Identity
- Trade Name
- Pregnancy(HCG)Rapid TestCassette(Coloidal Gold) EUDAMED
- Device Name
- Pregnancy(HCG)Rapid TestCassette(Coloidal Gold) EUDAMED
- Model / Reference
- 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box EUDAMEDGKPD026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698400495 EUDAMED
- Basic UDI-DI
- B-06977698400495 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC 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
Pregnancy(HCG)Rapid TestCassette(Coloidal 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-06977698400495 | 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 37f3f321-38f2-460e-bb0e-93b3cb3196a2 61 fields · synced Oct 7, 2026