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HbA1c Assay Kits (Lateral Flow Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 0320301101Model 10 Tests/KitRef 0320301102Model 50 Tests/Kit
Identity
- Trade Name
- HbA1c Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Device Name
- HbA1c Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 10 Tests/Kit EUDAMED0320301101 EUDAMED50 Tests/Kit EUDAMED0320301102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984067681 EUDAMED06975984067698 EUDAMED
- Basic UDI-DI
- B-06975984067681 EUDAMEDB-06975984067698 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-06975984067681 | 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 3a1781c5-55b7-41fd-b95f-b9d4c889e0da 61 fields · synced Jul 25, 2026
- EUDAMED ad089863-b542-4b49-864e-0d36155f21ea 61 fields · synced May 18, 2026