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Insulin-like Growth Factors-I (IGF-I) Detection Kit（Magnetic Solid Phase Chemil…

EUDAMED

Class IVD General (EU MDR)

Ref 50 Tests/kit（DR1112-1）Model 50 Tests/kitRef 100 Tests/kit（DR1112-2）Model 100 Tests/kit

by Biobase Diagnostic Technology (Shandong) Co., Ltd.

Identity

Trade Name
Insulin-like Growth Factors-I (IGF-I) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Device Name
Insulin-like Growth Factors-I (IGF-I) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Model / Reference
50 Tests/kit EUDAMED
50 Tests/kit（DR1112-1） EUDAMED
100 Tests/kit EUDAMED
100 Tests/kit（DR1112-2） EUDAMED

Identifiers

Primary DI / UDI-DI
06974969982766 EUDAMED
06974969982773 EUDAMED
Basic UDI-DI
B-06974969982766 EUDAMED
B-06974969982773 EUDAMED
EMDN Code
W0102060403 INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C) EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany 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-like Growth Factors-I (IGF-I) Detection Kit（Magnetic Solid Phase Chemil… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Biobase Diagnostic Technology (Shandong) Co., Ltd.
EUDAMED SRN
CN-MF-000025964
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (2)

  • EUDAMED b2c254fc-b033-4edc-8e92-8d5e898841f7 61 fields · synced Oct 6, 2026
  • EUDAMED cbfe20fd-8401-4ac7-9087-95bdd78a0b3e 61 fields · synced May 17, 2026