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ß-THALASSAEMIA & HbA1c Control Material
EUDAMEDClass C (EU MDR)
Ref 0320200701Model The kit includes Control Material Level 1, Level 2. 2×0.1mL
Identity
- Trade Name
- ß-THALASSAEMIA & HbA1c Control Material EUDAMED
- Device Name
- ß-THALASSAEMIA & HbA1c Control Material EUDAMED
- Model / Reference
- 0320200701 EUDAMEDThe kit includes Control Material Level 1, Level 2. 2×0.1mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062129 EUDAMED
- Basic UDI-DI
- 6970341680320200201JJ EUDAMEDB-06975984062129 EUDAMED
- EMDN Code
- W0103010504 HAEMOGLOBIN CONTROLS EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass 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
New Device
No
EUDAMED
ß-THALASSAEMIA & HbA1c Control Material by Shenzhen Lifotronic Technology Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6970341680320200201JJ | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 6970341680320200201JJ | Class C | 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 fbee0a4b-9a59-4ceb-928c-7962f5615436 61 fields · synced Jun 18, 2026
- EUDAMED 86897751-07f4-4cc2-8fa3-075e7c9ba9c9 61 fields · synced May 18, 2026