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Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemilumine…

EUDAMED

Class IVD General (EU MDR)

Ref 50 Tests/kit（DR1157-1）Model 50 Tests/kitRef 200 Tests/kit（DR1157-3）Model 200 Tests/kit

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

Identity

Trade Name
Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Device Name
Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Model / Reference
50 Tests/kit EUDAMED
50 Tests/kit（DR1157-1） EUDAMED
200 Tests/kit EUDAMED
200 Tests/kit（DR1157-3） EUDAMED

Identifiers

Primary DI / UDI-DI
06974969982940 EUDAMED
06974969982964 EUDAMED
Basic UDI-DI
B-06974969982940 EUDAMED
B-06974969982964 EUDAMED
EMDN Code
W0102030120 PROSTATIC ACID PHOSPHATASE (IC) 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

Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemilumine… 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 d4453e0a-5cde-4884-a750-aa2768521a88 61 fields · synced Oct 6, 2026
  • EUDAMED 76f186aa-6d25-4271-a290-a219bf47f544 61 fields · synced May 17, 2026