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Pregnancy-as-sociated Plasma Protein A（PAPP-A）Detection Kit（Magnetic Solid Phas…

EUDAMED

Class IVD General (EU MDR)

Ref 50 Tests/kit（DR1124-1）Model 50 Tests/kitRef 200 Tests/kit（DR1124-3）Model 200 Tests/kit

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

Identity

Trade Name
Pregnancy-as-sociated Plasma Protein A（PAPP-A）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Device Name
Pregnancy-as-sociated Plasma Protein A（PAPP-A）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Model / Reference
50 Tests/kit EUDAMED
50 Tests/kit（DR1124-1） EUDAMED
200 Tests/kit EUDAMED
200 Tests/kit（DR1124-3） EUDAMED

Identifiers

Primary DI / UDI-DI
06974969981509 EUDAMED
06974969982643 EUDAMED
Basic UDI-DI
B-06974969981509 EUDAMED
B-06974969982643 EUDAMED
EMDN Code
W0102050210 PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS) 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

Pregnancy-as-sociated Plasma Protein A（PAPP-A）Detection Kit（Magnetic Solid Phas… 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 5e16aa09-be91-403b-89de-87921e2dd2c7 61 fields · synced Oct 6, 2026
  • EUDAMED 32bc385f-be31-40ac-b322-ac80b9b7b85c 61 fields · synced May 16, 2026