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TB IgG/lgM Rapid Test Cassette (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref GKPD031Model 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX
Identity
- Trade Name
- TB IgG/lgM Rapid Test Cassette (Colloidal Gold) EUDAMED
- Device Name
- TB IgG/lgM Rapid Test Cassette (Colloidal Gold) EUDAMED
- Model / Reference
- 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX EUDAMEDGKPD031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698401416 EUDAMED
- Basic UDI-DI
- B-06977698401416 EUDAMED
- EMDN Code
- W0105010801 MYCOPLASMA 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
TB IgG/lgM 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-06977698401416 | 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 3ca1daf3-3881-4511-b611-cd480e687d63 61 fields · synced Jul 21, 2026