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Gastrin-17 Assay Kit （Chemiluminescence Immunoassay）
EUDAMEDClass IVD General (EU MDR)
Ref AB001102Model 25T, 50T, 2×50T, 100T, 2×100T
Identity
- Device Name
- Gastrin-17 Assay Kit （Chemiluminescence Immunoassay） EUDAMED
- Model / Reference
- 25T, 50T, 2×50T, 100T, 2×100T EUDAMEDAB001102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976964661011 EUDAMED
- Basic UDI-DI
- B-06976964661011 EUDAMED
- EMDN Code
- W0102069001 GASTRIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Gastrin-17 Assay Kit （Chemiluminescence Immunoassay） by Hunan AccuBio Biotech 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-06976964661011 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hunan AccuBio Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000041914
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED a880c0c8-9d2a-4d96-9be1-2e6de80755ea 61 fields · synced Jul 24, 2026