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Beta Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis)
EUDAMEDClass IVD General (EU MDR)
Ref 213001
Identity
- Trade Name
- Beta Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis) EUDAMED
- Device Name
- Beta Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis) EUDAMED
- Model / Reference
- 213001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931305141 EUDAMED
- Basic UDI-DI
- B-06955931305141 EUDAMED
- EMDN Code
- W0106010111 THALASSAEMIA 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
Beta Thalassemia Gene Assay 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-06955931305141 | 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 (1)
- EUDAMED efd31235-4b21-4630-a616-c50fedc449e7 61 fields · synced Jun 19, 2026