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HbA1c Control Material
EUDAMEDClass IVD General (EU MDR)
Ref 0320200301Model 2×0.1mL
Identity
- Trade Name
- HbA1c Control Material EUDAMED
- Device Name
- HbA1c Control Material EUDAMED
- Model / Reference
- 2×0.1mL EUDAMED0320200301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062044 EUDAMED
- Basic UDI-DI
- B-06975984062044 EUDAMED6970341680320200101JD EUDAMED
- EMDN Code
- W0103010201 HAEMOGLOBIN DETERMINATIONS (TOTAL HB) EUDAMEDW0101050205 DIABETES CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Italy EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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 Control Material by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06975984062044 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975984062044 | 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 (2)
- EUDAMED dd52ec80-c1fc-4a1a-8d6f-2749f17f0c2a 61 fields · synced Jul 20, 2026
- EUDAMED a881f47e-84ad-4ade-a1e0-dbde562130e3 61 fields · synced May 19, 2026