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Deletion Alpha Thalassemia Gene Assay Kit (Gap-PCR)
EUDAMEDClass IVD General (EU MDR)
Ref 212701
Identity
- Trade Name
- Deletion Alpha Thalassemia Gene Assay Kit (Gap-PCR) EUDAMED
- Device Name
- Deletion Alpha Thalassemia Gene Assay Kit (Gap-PCR) EUDAMED
- Model / Reference
- 212701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931305080 EUDAMED06955931305097 EUDAMED
- Basic UDI-DI
- B-06955931305080 EUDAMEDB-06955931305097 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 (Gap-PCR) 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-06955931305080 | 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 01fb7cc7-cee4-4b3f-8923-a4160a836f7b 61 fields · synced Jul 12, 2026
- EUDAMED f605ae76-606d-4323-9de3-d9372d4acff4 61 fields · synced May 17, 2026