swaromed

by Nissha Medical Technologies Ltd 68 variants

Ref 1033Model swaromed

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number506044191ECG-Elec1QZ Basic UDI-DI 05060441917799UDI-DI	Date21 Sep 2023Registered	StatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name: ECG Electrode
Model / Reference: swaromed, 1033

Primary DI / UDI-DI: 05060441917799
Basic UDI-DI: 506044191ECG-Elec1QZ
EMDN Code: C020501 ECG electrodes

Device Class: Class I
EU market of registration: France

Manufacturer details

EUDAMED SRN: GB-MF-000012057
Authorised representative: NISSHA MEDICAL TECHNOLOGIES SAS FR-AR-000009795

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Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No