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Syphilis (Tp) Ab Rapid Test Cassette (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref GKPD042Model 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box
Identity
- Trade Name
- Syphilis (Tp) Ab Rapid Test Cassette (Colloidal Gold) EUDAMED
- Device Name
- Syphilis (Tp) Ab Rapid Test Cassette (Colloidal Gold) EUDAMED
- Model / Reference
- 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box EUDAMEDGKPD042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698402284 EUDAMED
- Basic UDI-DI
- B-06977698402284 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER 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
Syphilis (Tp) Ab 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-06977698402284 | 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 5d6116eb-48ef-4bb2-960d-2dcd1149e1ed 61 fields · synced Jun 20, 2026