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Insulin (INS) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 25 Tests/KitRef 100 Tests/KitRef 50 Tests/Kit
Identity
- Trade Name
- Insulin (INS) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Insulin (INS) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED100 Tests/Kit EUDAMED50 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986814866 EUDAMED06974986814880 EUDAMED06974986814873 EUDAMED
- Basic UDI-DI
- B-06974986814866 EUDAMEDB-06974986814880 EUDAMEDB-06974986814873 EUDAMED
- EMDN Code
- W0102060103 INSULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Insulin (INS) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock 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-06974986814866 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED db2a47ea-6ae7-49a9-b36f-7234214b80e7 61 fields · synced Oct 6, 2026
- EUDAMED 7b8a7360-5e77-4072-bc81-5ceecd77d232 61 fields · synced May 17, 2026
- EUDAMED cdd5ab76-732e-4ae9-9457-432f5a6587ad 61 fields · synced May 18, 2026