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Sample Pretreatment Kit for DNA Methylation Test
EUDAMEDClass A (EU MDR)
Ref 250501Model MBS-16C; MBS-48F
Identity
- Trade Name
- Sample Pretreatment Kit for DNA Methylation Test EUDAMED
- Device Name
- Sample Pretreatment Kit for DNA Methylation Test EUDAMED
- Model / Reference
- MBS-16C; MBS-48F EUDAMED250501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931303093 EUDAMED
- Basic UDI-DI
- 695593130025050001KL EUDAMED
- Direct Marketing DI
- 06955931303093 EUDAMED
- EMDN Code
- W0105900103 SUPPLEMENTAL NA REAGENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Sample Pretreatment Kit for DNA Methylation Test by Yaneng BIOscience (Shenzhen) Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 695593130025050001KL | Class A | 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 (1)
- EUDAMED 3ccb800d-fc89-4e48-9995-4bac81911166 61 fields · synced Jun 19, 2026