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IGF-1 Insulin-Like Growth Factor 1 (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref IGF-1706-AE10Y, IGF-1706-AE10N, IGF-1706-AE20Y, IGF-1706-AE20N
Identity
- Trade Name
- IGF-1 Insulin-Like Growth Factor 1 (CLIA) EUDAMED
- Device Name
- IGF-1 Insulin-Like Growth Factor 1 (CLIA) EUDAMED
- Model / Reference
- IGF-1706-AE10Y, IGF-1706-AE10N, IGF-1706-AE20Y, IGF-1706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-IGF-1706-AE2V EUDAMED
- Basic UDI-DI
- B-IGF-1706-AE2V EUDAMED
- EMDN Code
- W0102060403 INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
IGF-1 Insulin-Like Growth Factor 1 (CLIA) by Hangzhou Aichek Medical Technology 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-IGF-1706-AE2V | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 426606a7-69e7-4728-afec-156648826a5d 61 fields · synced Oct 6, 2026
- EUDAMED 426606a7-69e7-4728-afec-156648826a5d-1 61 fields · synced Jul 30, 2026