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Procollagen III N-terminal Peptide（PIIINP）Detection Kit（Magnetic Solid Phase Ch…

EUDAMED

Class IVD General (EU MDR)

Ref 200 Tests/kit（DR1072-3）Model 200 Tests/kitRef 100 Tests/kit（DR1072-2）Model 100 Tests/kitRef 50 Tests/kit（DR1072-1）Model 50 Tests/kit

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

Identity

Trade Name
Procollagen III N-terminal Peptide（PIIINP）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Device Name
Procollagen III N-terminal Peptide（PIIINP）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
Model / Reference
200 Tests/kit EUDAMED
200 Tests/kit（DR1072-3） EUDAMED
100 Tests/kit EUDAMED
100 Tests/kit（DR1072-2） EUDAMED
50 Tests/kit EUDAMED
50 Tests/kit（DR1072-1） EUDAMED

Identifiers

Primary DI / UDI-DI
06974969982261 EUDAMED
06974969981691 EUDAMED
06974969981127 EUDAMED
Basic UDI-DI
B-06974969982261 EUDAMED
B-06974969981691 EUDAMED
B-06974969981127 EUDAMED
EMDN Code
W0102120104 PROCOLLAGEN III AMINO TERMINAL PEPTIDE 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

Procollagen III N-terminal Peptide（PIIINP）Detection Kit（Magnetic Solid Phase Ch… 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 db9aa1ac-008b-41bc-8333-4612f7eddf15 61 fields · synced Oct 6, 2026
  • EUDAMED 6e8f355c-dca9-4bdb-9fbe-99900c856c83 61 fields · synced May 17, 2026
  • EUDAMED beebf48b-6124-4c26-a9e4-5e81ace3ba6c 61 fields · synced May 19, 2026