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HbA1c Control Material
EUDAMEDClass IVD General (EU MDR)
Ref 55605Model The kit includes Control Material Level 1 and Level 2 2 × 0.1mL / vialsRef 0320200302Model Level 1: 1×0.5mL; Level 2: 1×0.5mL
Identity
- Trade Name
- HbA1c Control Material EUDAMED
- Device Name
- HbA1c Control Material EUDAMED
- Model / Reference
- The kit includes Control Material Level 1 and Level 2 2 × 0.1mL / vials EUDAMED55605 EUDAMEDLevel 1: 1×0.5mL; Level 2: 1×0.5mL EUDAMED0320200302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139078303 EUDAMED06970341684983 EUDAMED
- Basic UDI-DI
- B-06978139078303 EUDAMEDB-06970341684983 EUDAMED6970341680320200101JD EUDAMED
- EMDN Code
- W0103010504 HAEMOGLOBIN CONTROLS EUDAMEDW0101050205 DIABETES CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Germany 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-06978139078303 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06978139078303 | 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 (3)
- EUDAMED 90ef48ec-ba57-4170-a848-f3223ac2386d 61 fields · synced Jul 30, 2026
- EUDAMED 706fd95c-c6d6-439f-8fe3-88bd9530cddd 61 fields · synced May 17, 2026
- EUDAMED a429981d-eb7c-4dbe-bb56-31f696a8c2c6 61 fields · synced May 17, 2026