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SW-NEMS-Web

EUDAMED

Class IIa (EU MDR)

Ref HASP-SW-K-NEMS-WEB-01Model PC-ECG 1200 Software-Options

by Norav Medical GmbH

Identity

Trade Name
SW-NEMS-Web EUDAMED
Device Name
PC-ECG 1200 Series EUDAMED
Model / Reference
PC-ECG 1200 Software-Options EUDAMED
HASP-SW-K-NEMS-WEB-01 EUDAMED

Identifiers

Primary DI / UDI-DI
04260498568192 EUDAMED
Basic UDI-DI
426049856DE55252NMKEYVQ EUDAMED
Direct Marketing DI
04260498568192 EUDAMED
EMDN Code
Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Special Device Type
Software EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

SW-NEMS-Web by Norav Medical GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Norav Medical GmbH
EUDAMED SRN
DE-MF-000006715

Sources (1)

  • EUDAMED 3bd5a608-3d3e-4fca-97fa-98c82928811f 61 fields · synced Jul 9, 2026