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Anti-Müllerian Hormone (AMH) Detection Kit（Magnetic Solid Phase Chemiluminescen…

EUDAMED

Class IVD General (EU MDR)

Ref 200 Tests/kit（DR1114-3）Model 200 Tests/kitRef 50 Tests/kit（DR1114-1）Model 50 Tests/kit

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

Identity

Trade Name
Anti-Müllerian Hormone (AMH) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Device Name
Anti-Müllerian Hormone (AMH) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Model / Reference
200 Tests/kit EUDAMED
200 Tests/kit（DR1114-3） EUDAMED
50 Tests/kit EUDAMED
50 Tests/kit（DR1114-1） EUDAMED

Identifiers

Primary DI / UDI-DI
06974969982728 EUDAMED
06974969982704 EUDAMED
Basic UDI-DI
B-06974969982728 EUDAMED
B-06974969982704 EUDAMED
EMDN Code
W0102050215 ANTI-MULLERIAN HORMONE 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

Anti-Müllerian Hormone (AMH) Detection Kit（Magnetic Solid Phase Chemiluminescen… 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 (3)

  • EUDAMED 6c99d8ea-7904-4f8f-a11b-a9c100631c81 61 fields · synced Jul 15, 2026
  • EUDAMED 8ac01023-e12c-48e8-9002-b1f0e0387b1c 61 fields · synced May 17, 2026
  • EUDAMED 15d8db3c-351d-4161-8518-eebef648c219 61 fields · synced Jul 15, 2026