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

EUDAMED

Class C (EU MDR)

Ref 691049Model 50T, 2×50T, 100T, 2×100TModel 100T

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
691049 EUDAMED
100T EUDAMED

Identifiers

Primary DI / UDI-DI: 06970341689261 EUDAMED
Basic UDI-DI: 69703416803205037JJ EUDAMED
B-06970341689261 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 bf00beed-ef1c-455b-8eca-a16d5c0d6894 61 fields · synced Jun 18, 2026
EUDAMED 544b3c04-1258-4862-a0a7-5a1dd49d07e6 61 fields · synced May 19, 2026