N-terminal pro-B-type Natriuretic Peptide &Cardiac Troponin I Combo Test Kit (F…

EUDAMED

Class IVD General (EU MDR)

Ref /

by Shenzhen Reetoo Biotechnology Co., Ltd

Identity

Device Name: N-terminal pro-B-type Natriuretic Peptide &Cardiac Troponin I Combo Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
Model / Reference: / EUDAMED

Identifiers

Primary DI / UDI-DI: D-K90411-018PG EUDAMED
Basic UDI-DI: B-K90411-018PG EUDAMED
EMDN Code: W01021399 CARDIAC MARKERS - OTHER EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Italy EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

N-terminal pro-B-type Natriuretic Peptide &Cardiac Troponin I Combo Test Kit (F… by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-K90411-018PG	Class IVD General	Active

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Manufacturer

Manufacturer: Shenzhen Reetoo Biotechnology Co., Ltd
EUDAMED SRN: CN-MF-000011699
Authorised Representative: Umedwings Netherlands B.V. NL-AR-000000444

Sources (1)

EUDAMED 0cbcdc24-14b9-4d45-b24e-6de53d7075da 61 fields · synced Jun 18, 2026