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EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic As…
EUDAMEDClass IVD General (EU MDR)
Ref NPC010-100
Identity
- Device Name
- EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay) EUDAMED
- Model / Reference
- NPC010-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975977120102 EUDAMED
- Basic UDI-DI
- B-06975977120102 EUDAMED
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic As… by Shenzhen Genebiohealth Co., Ltd. — Class IVD General — IVDD — listed in…
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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-06975977120102 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Genebiohealth Co., Ltd.
- EUDAMED SRN
- CN-MF-000046424
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 2666207d-a4cb-48da-aab0-a1dd6c34dda5 61 fields · synced Jun 20, 2026