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Gastrin-17 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2022E-75Ref S2022E-100Ref S2022E-150Ref S2022E-50Ref S2022E-25
Identity
- Device Name
- Gastrin-17 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2022E-75 EUDAMEDS2022E-100 EUDAMEDS2022E-150 EUDAMEDS2022E-50 EUDAMEDS2022E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737563 EUDAMED06955792737570 EUDAMED06955792737587 EUDAMED06955792737556 EUDAMED06955792737549 EUDAMED
- Basic UDI-DI
- B-06955792737563 EUDAMEDB-06955792737570 EUDAMEDB-06955792737587 EUDAMEDB-06955792737556 EUDAMEDB-06955792737549 EUDAMED
- EMDN Code
- W0102030121 PRO-GASTRIN-RELEASING PEPTIDE EUDAMEDW01020401 FREE TRIIODOTHYRONINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792737563 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED 610a2dfd-5953-419e-ab6f-ae347d5c1563 61 fields · synced Jul 24, 2026
- EUDAMED 5bb05c0c-0119-4d1d-811a-b2a31e91a794 61 fields · synced May 17, 2026
- EUDAMED 4a12cc27-f2ab-417f-9809-846d149e3900 61 fields · synced May 18, 2026
- EUDAMED a1d5aed7-bc6c-4d30-bf0a-6544c2b87112 61 fields · synced May 18, 2026
- EUDAMED ccc14091-80f1-433c-9f40-d4a2f6735970 61 fields · synced May 19, 2026