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Insulin (Electrochemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref 695027Model 50T, 2×50T, 100T, 2×100TModel 2×100T
Identity
- Trade Name
- Insulin (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Insulin (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 50T, 2×50T, 100T, 2×100T EUDAMED695027 EUDAMED2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341681210 EUDAMED
- Basic UDI-DI
- 69703416803205044JF EUDAMEDB-06970341681210 EUDAMED
- EMDN Code
- W0102060103 INSULIN EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass 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
New Device
No
EUDAMED
Insulin (Electrochemiluminescence Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class B — IVDD, IVDR — listed in EUDAMED
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 | 69703416803205044JF | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 69703416803205044JF | Class B | 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 f7781297-4990-43b6-81e5-be92b8408af5 61 fields · synced Jul 20, 2026
- EUDAMED 7d69983f-4903-4071-935a-e8e2c0e7df3c 61 fields · synced May 19, 2026