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Immunoglobulin E (IgE) Detection Kit（Magnetic Solid Phase Chemiluminescent Immu…

EUDAMED

Class IVD General (EU MDR)

Ref 100 Tests/kit（DR1139-2）Model 100 Tests/kitRef 200 Tests/kit（DR1139-3）Model 200 Tests/kit

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

Identity

Trade Name
Immunoglobulin E (IgE) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Device Name
Immunoglobulin E (IgE) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Model / Reference
100 Tests/kit EUDAMED
100 Tests/kit（DR1139-2） EUDAMED
200 Tests/kit EUDAMED
200 Tests/kit（DR1139-3） EUDAMED

Identifiers

Primary DI / UDI-DI
06974969982896 EUDAMED
06974969982902 EUDAMED
Basic UDI-DI
B-06974969982896 EUDAMED
B-06974969982902 EUDAMED
EMDN Code
W01020201 IMMUNOGLOBULIN E - TOTAL 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

Immunoglobulin E (IgE) Detection Kit（Magnetic Solid Phase Chemiluminescent Immu… 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 c7258b3f-6151-41e2-8e15-0eff578ba474 61 fields · synced Oct 6, 2026
  • EUDAMED 123b862d-fbc2-41e7-aa7a-f8e8e2ae183e 61 fields · synced May 18, 2026