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Genetic Deafness Gene Testing Kit (Multicolor Melting Curve Analysis)
EUDAMEDClass IVD General (EU MDR)
Ref 213401
Identity
- Trade Name
- Genetic Deafness Gene Testing Kit (Multicolor Melting Curve Analysis) EUDAMED
- Device Name
- Genetic Deafness Gene Testing Kit (Multicolor Melting Curve Analysis) EUDAMED
- Model / Reference
- 213401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931305165 EUDAMED06955931305172 EUDAMED
- Basic UDI-DI
- B-06955931305165 EUDAMEDB-06955931305172 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
Genetic Deafness Gene Testing Kit (Multicolor Melting Curve Analysis) 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-06955931305165 | 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 5d8db299-4730-4a93-9190-07e8f1d66025 61 fields · synced Jul 19, 2026
- EUDAMED 5303ccc7-f9dc-4fb4-872d-65bfc8882f95 61 fields · synced May 19, 2026