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ß-THALASSAEMIA & HbA1c Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref 0320200201Model The kit includes calibrator level 1, level 2. 2×0.1mLRef 0320200601
Identity
- Trade Name
- ß-THALASSAEMIA & HbA1c Calibrator EUDAMED
- Device Name
- ß-THALASSAEMIA & HbA1c Calibrator EUDAMED
- Model / Reference
- The kit includes calibrator level 1, level 2. 2×0.1mL EUDAMED0320200201 EUDAMED0320200601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062082 EUDAMED
- Basic UDI-DI
- B-06975984062082 EUDAMED6970341680320200202JL EUDAMED
- EMDN Code
- W0103010507 WHOLE BLOOD CALIBRATORS 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
ß-THALASSAEMIA & HbA1c Calibrator by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED
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-06975984062082 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975984062082 | 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 936814d1-4d0b-402e-b49f-afe78a592682 61 fields · synced Jul 22, 2026
- EUDAMED d959c9bf-cac4-4eb3-90dc-1c4b5055de55 61 fields · synced May 18, 2026