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HbA1c Assay Kits (Lateral Flow Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 745011Model 25 Tests/Kit
Identity
- Trade Name
- HbA1c Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Device Name
- HbA1c Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED745011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139075814 EUDAMED
- Basic UDI-DI
- B-06978139075814 EUDAMED
- EMDN Code
- W0101060107 HBA1C TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
HbA1c Assay Kits (Lateral Flow Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06978139075814 | 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 (1)
- EUDAMED 769ef36a-d4e3-4c3c-a7ad-08e71cef82a0 61 fields · synced Jun 19, 2026