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Reprimo and CABIN1 DNA Methylation Detection Kit (Fluorescence PCR Assay)
EUDAMEDClass IVD General (EU MDR)
Ref GC010-48
Identity
- Device Name
- Reprimo and CABIN1 DNA Methylation Detection Kit (Fluorescence PCR Assay) EUDAMED
- Model / Reference
- GC010-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975977120065 EUDAMED
- Basic UDI-DI
- B-06975977120065 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - 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
Reprimo and CABIN1 DNA Methylation Detection Kit (Fluorescence PCR Assay) by Shenzhen Genebiohealth 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-06975977120065 | 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 09ae3400-4114-420f-b1a1-2d2f8613f514 61 fields · synced Oct 6, 2026