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Insulin-Like Growth Factor-Ⅰ Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2032E-25Ref S2032E-50Ref S2032E-200Ref S2032E-100
Identity
- Device Name
- Insulin-Like Growth Factor-Ⅰ Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2032E-25 EUDAMEDS2032E-50 EUDAMEDS2032E-200 EUDAMEDS2032E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792738744 EUDAMED06955792738751 EUDAMED06955792738799 EUDAMED06955792738775 EUDAMED
- Basic UDI-DI
- B-06955792738744 EUDAMEDB-06955792738751 EUDAMEDB-06955792738799 EUDAMEDB-06955792738775 EUDAMED
- EMDN Code
- W0102060405 INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1 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
Insulin-Like Growth Factor-Ⅰ Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792738744 | 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 (4)
- EUDAMED 0751cdbf-20d4-4c05-8a09-12d709fae178 61 fields · synced Jul 31, 2026
- EUDAMED e2376448-bf78-47ca-b8cb-9d20de401c0c 61 fields · synced May 16, 2026
- EUDAMED 995c003e-7770-423b-8761-4902ed405037 61 fields · synced May 17, 2026
- EUDAMED cd6a092b-7163-4e2b-9716-1abf97c667eb 61 fields · synced May 17, 2026