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N-terminal Peptide of Type Ⅲ Procollagen(PⅢNP)Assay Kit

EUDAMED

Class IVD General (EU MDR)

Ref 69543760F0005068Model 100 TestsRef 25 testsModel 25 tests，50 tests，2×50 tests，100 tests，2×100 testsRef 50 testsRef 2×100 test

by Beijing Leadman Biochemistry Co., Ltd.

Identity

Trade Name
N-terminal Peptide of Type Ⅲ Procollagen(PⅢNP)Assay Kit EUDAMED
N-terminal Peptide of Procollagen Type III Assay kit(Chemiluminescence Immunoassay Method） EUDAMED
Device Name
N-terminal Peptide of Type Ⅲ Procollagen(PⅢNP)Assay Kit EUDAMED
N-terminal Peptide of Procollagen Type III Assay kit(Chemiluminescence Immunoassay Method） EUDAMED
Model / Reference
100 Tests EUDAMED
69543760F0005068 EUDAMED
25 tests，50 tests，2×50 tests，100 tests，2×100 tests EUDAMED
25 tests EUDAMED
50 tests EUDAMED
2×100 test EUDAMED

Identifiers

Primary DI / UDI-DI
06954376005333 EUDAMED
06978465235555 EUDAMED
06978465235562 EUDAMED
06978465235593 EUDAMED
Basic UDI-DI
B-06954376005333 EUDAMED
697846523ProteinB08RN EUDAMED
EMDN Code
W0102120104 PROCOLLAGEN III AMINO TERMINAL PEPTIDE EUDAMED
W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class B EUDAMED
Market of Registration
Germany EUDAMED
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

N-terminal Peptide of Type Ⅲ Procollagen(PⅢNP)Assay Kit by Beijing Leadman Biochemistry Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Beijing Leadman Biochemistry Co., Ltd.
EUDAMED SRN
CN-MF-000020150
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED f88184dd-26f9-42df-bbcc-ada2718e7450 61 fields · synced Oct 6, 2026
  • EUDAMED 20774d36-2c7e-4f64-b3c3-a2d11a2798b7 61 fields · synced Jul 9, 2026
  • EUDAMED 30dc57f7-d28f-4ab6-a1e8-b0def517b702 61 fields · synced Jul 10, 2026
  • EUDAMED 5eacff4c-da8c-4651-84a8-5171420a91e4 61 fields · synced Jul 13, 2026