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ß-THALASSAEMIA & HbA1c Assay Column (HPLC)
EUDAMEDClass IVD General (EU MDR)
Ref 0320209Model H8
Identity
- Device Name
- ß-THALASSAEMIA & HbA1c Assay Column (HPLC) EUDAMED
- Model / Reference
- H8 EUDAMED0320209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341680442 EUDAMED
- Basic UDI-DI
- B-06970341680442 EUDAMED
- EMDN Code
- W0201050201 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
ß-THALASSAEMIA & HbA1c Assay Column (HPLC) by Shenzhen Lifotronic Technology 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-06970341680442 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f247b9c0-baa0-4e6a-800d-62f6e884d4be 61 fields · synced Jun 17, 2026