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ß-THALASSAEMIA & HbA1c Reagent Kit (HPLC)
EUDAMEDClass A (EU MDR)
Ref 0320201205
Identity
- Trade Name
- ß-THALASSAEMIA & HbA1c Reagent Kit (HPLC) EUDAMED
- Device Name
- ß-THALASSAEMIA & HbA1c Reagent Kit (HPLC) EUDAMED
- Model / Reference
- 0320201205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341680459 EUDAMED
- Basic UDI-DI
- 69703416803202027HS EUDAMED
- EMDN Code
- W0106010111 THALASSAEMIA EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
New Device
No
EUDAMED
ß-THALASSAEMIA & HbA1c Reagent Kit (HPLC) by Shenzhen Lifotronic Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69703416803202027HS | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED b943d3f4-638e-4ad1-be94-7f38e264ff53 61 fields · synced Jul 11, 2026