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DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Ti…
EUDAMEDClass IVD General (EU MDR)
Ref L000048Model 200 tests/kitRef EH001C-200 200 tests/kit
Identity
- Trade Name
- DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Time PCR） EUDAMEDDNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR) EUDAMED
- Device Name
- DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Time PCR） EUDAMEDDNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR) EUDAMED
- Model / Reference
- 200 tests/kit EUDAMEDL000048 EUDAMEDEH001C-200 200 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583193 EUDAMED06974643920145 EUDAMED
- Basic UDI-DI
- B-06974968583193 EUDAMED697464392METH01RW EUDAMED
- EMDN Code
- W01060214 COLORECTAL CANCER (MSI-H / DMMR) EUDAMEDW010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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
New Device
No
EUDAMED
DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Ti… by GeneMind Biosciences Co., Ltd. — Class IVD General — IVDR, IVDD — listed…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06974968583193 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06974968583193 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- GeneMind Biosciences Co., Ltd.
- EUDAMED SRN
- CN-MF-000025785
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 3bfebadd-7fa3-4b4a-8371-83a0c7cf98a3 61 fields · synced Aug 2, 2026
- EUDAMED f48cf39d-a765-4cd8-9191-b5354bc31f41 61 fields · synced May 18, 2026