N-terminal pro B-type Natriuretic Peptide STAT (NT-proBNP STAT) eCLIA

EUDAMED

Class C (EU MDR)

Ref 691048Model 50T, 2×50T, 100T, 2×100TModel 2×50T

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name: N-terminal pro B-type Natriuretic Peptide STAT (NT-proBNP STAT) eCLIA EUDAMED
Device Name: N-terminal pro B-type Natriuretic Peptide STAT (NT-proBNP STAT) eCLIA EUDAMED
Model / Reference: 50T, 2×50T, 100T, 2×100T EUDAMED
691048 EUDAMED
2×50T EUDAMED

Identifiers

Primary DI / UDI-DI: 06975984063348 EUDAMED
Basic UDI-DI: 69703416803205037JJ EUDAMED
B-06975984063348 EUDAMED
EMDN Code: W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED

Classification

Device Class: Class C EUDAMED
Class IVD General EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

N-terminal pro B-type Natriuretic Peptide STAT (NT-proBNP STAT) eCLIA by Shenzhen Lifotronic Technology Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	69703416803205037JJ	Class C	Active
EUDAMED	European Union	CE/IVDR	69703416803205037JJ	Class C	Active

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Manufacturer

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
EUDAMED SRN: CN-MF-000005654
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

EUDAMED 4211c753-b983-4213-8071-b4063c60b0fa 61 fields · synced Aug 1, 2026
EUDAMED e7039bef-c574-4814-ba0c-ac50a97fb019 61 fields · synced May 19, 2026