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Spinal Muscular Atrophy Genetic Testing Kit (PCR-Fluorescence Probing)
EUDAMEDClass IVD General (EU MDR)
Ref 211701
Identity
- Trade Name
- Spinal Muscular Atrophy Genetic Testing Kit (PCR-Fluorescence Probing) EUDAMEDSpinal Muscular Atrophy Genetic Testing Kit（PCR-Fluorescence Probing） EUDAMED
- Device Name
- Spinal Muscular Atrophy Genetic Testing Kit (PCR-Fluorescence Probing) EUDAMEDSpinal Muscular Atrophy Genetic Testing Kit（PCR-Fluorescence Probing） EUDAMED
- Model / Reference
- 211701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931303031 EUDAMED06955931303024 EUDAMED
- Basic UDI-DI
- B-06955931303031 EUDAMEDB-06955931303024 EUDAMED
- EMDN Code
- W0106010199 MONOGENETIC DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
Spinal Muscular Atrophy Genetic Testing Kit (PCR-Fluorescence Probing) by Yaneng BIOscience (Shenzhen) 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-06955931303031 | 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 b6c9da23-d227-4521-98a5-e5a7ed82f08f 61 fields · synced Jul 12, 2026
- EUDAMED d6aefc18-e8da-46f9-ac20-74f6f6a1f7a9 61 fields · synced May 19, 2026