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Deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis)
EUDAMEDClass IVD General (EU MDR)
Ref 212201
Identity
- Trade Name
- Deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis) EUDAMED
- Device Name
- Deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis) EUDAMED
- Model / Reference
- 212201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931304984 EUDAMED06955931304977 EUDAMED
- Basic UDI-DI
- B-06955931304984 EUDAMEDB-06955931304977 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
Deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis) by Yaneng BIOscience (Shenzhen) Co., Ltd. — Class IVD General — IVDD — listed in…
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-06955931304984 | 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 a421b554-39f3-4d11-a9e1-dbd8cf02bd63 61 fields · synced Jul 21, 2026
- EUDAMED 06af05bc-4c60-4ba7-8bd8-9a0b2ca14142 61 fields · synced May 19, 2026