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ß-THALASSAEMIA & HbA1c Calibrator

EUDAMED

Class IVD General (EU MDR)

Ref 56149Model The kit includes calibrator level 1, level 2, 2×0.1mLRef 55606Model The kit includes calibrator level 1and level 2 2 × 0.1 mL / vials

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name
ß-THALASSAEMIA & HbA1c Calibrator EUDAMED
HbA1c Calibrator EUDAMED
Device Name
ß-THALASSAEMIA & HbA1c Calibrator EUDAMED
HbA1c Calibrator EUDAMED
Model / Reference
The kit includes calibrator level 1, level 2, 2×0.1mL EUDAMED
56149 EUDAMED
The kit includes calibrator level 1and level 2 2 × 0.1 mL / vials EUDAMED
55606 EUDAMED

Identifiers

Primary DI / UDI-DI
06978139078310 EUDAMED
06978139078297 EUDAMED
Basic UDI-DI
B-06978139078310 EUDAMED
B-06978139078297 EUDAMED
EMDN Code
W0103010507 WHOLE BLOOD CALIBRATORS EUDAMED

Classification

Device Class
Class IVD General 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

ß-THALASSAEMIA & HbA1c Calibrator by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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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 6fe240c9-7a5d-4f91-b4ee-bf28c7e2fcf4 61 fields · synced Jul 27, 2026
  • EUDAMED 9f072f71-1beb-40ec-86b4-b2e0636bbf41 61 fields · synced May 19, 2026