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DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Ti…
EUDAMEDClass IVD General (EU MDR)
Ref L000045;L000048Model 50 tests/kit
Identity
- Trade Name
- DNA 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） EUDAMED
- Model / Reference
- 50 tests/kit EUDAMEDL000045;L000048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583186 EUDAMED
- Basic UDI-DI
- B-06974968583186 EUDAMED
- EMDN Code
- W01060214 COLORECTAL CANCER (MSI-H / DMMR) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Ti… by GeneMind Biosciences Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974968583186 | 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 cd5ac2c3-fccf-4f0d-96ef-63d63873d57b 61 fields · synced Jun 19, 2026
- EUDAMED cd5ac2c3-fccf-4f0d-96ef-63d63873d57b-1 61 fields · synced Jun 10, 2026