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Gastrin-17 (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320500102Model 2×100TRef 0320500101Model 100TModel 2×50T
Identity
- Trade Name
- Gastrin-17 (eCLIA) EUDAMED
- Device Name
- Gastrin-17 (eCLIA) EUDAMED
- Model / Reference
- 2×100T EUDAMED0320500102 EUDAMED100T EUDAMED0320500101 EUDAMED2×50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062976 EUDAMED06975984062556 EUDAMED06975984062969 EUDAMED
- Basic UDI-DI
- B-06975984062976 EUDAMEDB-06975984062556 EUDAMEDB-06975984062969 EUDAMED
- EMDN Code
- W0102069001 GASTRIN 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
EUDAMEDEUDAMED
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
Gastrin-17 (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975984062976 | 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 (3)
- EUDAMED 673dc72c-15ea-4a03-b0e3-91fba12313fe 61 fields · synced Jul 30, 2026
- EUDAMED 0aa5b85e-874d-4751-b8ef-d43fbfe0ad96 61 fields · synced May 17, 2026
- EUDAMED cee92bb7-3f00-47e4-a720-5116fdc1bb41 61 fields · synced May 19, 2026