← Back to catalogue
THALASSAEMIA & HbA1c Reagent Kit (HPLC)
EUDAMEDClass A (EU MDR)
Ref 0320201205Model 200T, 400TRef 0320201206
Identity
- Trade Name
- THALASSAEMIA & HbA1c Reagent Kit (HPLC) EUDAMED
- Model / Reference
- 200T, 400T EUDAMED0320201205 EUDAMED0320201206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984066066 EUDAMED06975984066073 EUDAMED
- Basic UDI-DI
- 69703416803202026HQ EUDAMED
- EMDN Code
- W0103010299 OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER 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
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 | 69703416803202026HQ | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 87fc610d-9f7f-4925-a628-5ed56b9fe165 61 fields · synced Jul 17, 2026
- EUDAMED 0c62668c-6617-4c60-9a26-e71601d6b8ab 61 fields · synced May 18, 2026