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Gastrin-17 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 50tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit
Identity
- Device Name
- Gastrin-17 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EUDAMED50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719604708 EUDAMED06972719603008 EUDAMED06972719602995 EUDAMED
- Basic UDI-DI
- B-06972719604708 EUDAMEDB-06972719603008 EUDAMEDB-06972719602995 EUDAMED
- EMDN Code
- W0102069001 GASTRIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Gastrin-17 Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06972719604708 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000024838
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED e5ce883f-9a8f-462a-afdd-4a9f0285418f 61 fields · synced Oct 7, 2026
- EUDAMED 0161431f-8e6e-4826-bf4c-cbc971326dd5 61 fields · synced May 17, 2026
- EUDAMED 079f53d8-09ea-4367-a2f2-d7044b12de29 61 fields · synced May 18, 2026