← Back to catalogue
Non-deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysi…
EUDAMEDClass IVD General (EU MDR)
Ref 212301
Identity
- Trade Name
- Non-deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis) EUDAMED
- Device Name
- Non-deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis) EUDAMED
- Model / Reference
- 212301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931305004 EUDAMED06955931304991 EUDAMED
- Basic UDI-DI
- B-06955931305004 EUDAMEDB-06955931304991 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
Non-deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysi… by Yaneng BIOscience (Shenzhen) Co., Ltd. — Class IVD General — IVDD — listed…
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-06955931305004 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013666
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 76f510a7-612d-4f74-a2ef-b57a2c47ad3b 61 fields · synced Jul 17, 2026
- EUDAMED 418264e2-7119-4969-b396-80fca386b3e4 61 fields · synced May 19, 2026