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DNA Methylation Detection Kit for Human PCDH17, POU4F2 and PENK Gene (Real-Time…
EUDAMEDClass IVD General (EU MDR)
Ref 213101
Identity
- Trade Name
- DNA Methylation Detection Kit for Human PCDH17, POU4F2 and PENK Gene (Real-Time PCR) EUDAMED
- Device Name
- DNA Methylation Detection Kit for Human PCDH17, POU4F2 and PENK Gene (Real-Time PCR) EUDAMED
- Model / Reference
- 213101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931305189 EUDAMED06955931305196 EUDAMED
- Basic UDI-DI
- B-06955931305189 EUDAMEDB-06955931305196 EUDAMED
- EMDN Code
- W01060215 BLADDER CANCER DETECTION / MONITORING EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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 PCDH17, POU4F2 and PENK Gene (Real-Time… by Yaneng BIOscience (Shenzhen) Co., Ltd. — Class IVD General — IVDD — listed…
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-06955931305189 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013666
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 24f8b6ca-18c3-4578-9f15-0e34ad0850c1 61 fields · synced Jul 18, 2026
- EUDAMED 5b6f869e-503a-4351-a5cf-9474bf5d09d6 61 fields · synced May 19, 2026