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HbA1c Reagent Kits (HPLC)
EUDAMEDClass A (EU MDR)
Ref 0320201001Model 100T, 200T, 400T
Identity
- Trade Name
- HbA1c Reagent Kits (HPLC) EUDAMED
- Device Name
- HbA1c Reagent Kits (HPLC) EUDAMED
- Model / Reference
- 100T, 200T, 400T EUDAMED0320201001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984065816 EUDAMED
- Basic UDI-DI
- 69703416803202029HW 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
HbA1c Reagent Kits (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 | 69703416803202029HW | 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 96e65286-ce73-4f5f-8cfc-0fa6596e63ac 61 fields · synced Jul 24, 2026