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IGFBP-3 (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320509503Model 100 TRef 0320509501Model 50T Ref 0320509502Model 2×50 T
Identity
- Trade Name
- IGFBP-3 (eCLIA) EUDAMED
- Device Name
- IGFBP-3 (eCLIA) EUDAMED
- Model / Reference
- 100 T EUDAMED0320509503 EUDAMED50T EUDAMED0320509501 EUDAMED2×50 T EUDAMED0320509502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984064079 EUDAMED06975984064055 EUDAMED06975984064062 EUDAMED
- Basic UDI-DI
- B-06975984064079 EUDAMEDB-06975984064055 EUDAMEDB-06975984064062 EUDAMED
- EMDN Code
- W0102060406 INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
IGFBP-3 (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — 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-06975984064079 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED feb64e6e-2c66-4c34-be1e-b6a8b34f3466 61 fields · synced Jul 30, 2026
- EUDAMED 5e73c52f-2d46-4edb-bea5-b6fbb6be8101 61 fields · synced May 17, 2026
- EUDAMED c1033171-5ec9-4d66-8454-04116e43d088 61 fields · synced May 18, 2026