ECG Leadwires and Trunk Cable

by Orantech Inc. 453 variants

Ref ECG Leadwires and Trunk Cable

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69416919ORANTECH01QP Basic UDI-DI	Date15 Nov 2023Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: ECG Leadwires
Model / Reference: ECG Leadwires and Trunk Cable

Primary DI / UDI-DI: 06941691930655, 06941691928539, 06941691929413, 06941691929826, 06941691929765
Basic UDI-DI: 69416919ORANTECH01QP
EMDN Code: Z1203020285 Multi-parameter monitors - consumables

Device Class: Class I
EU market of registration: Denmark

Manufacturer details

EUDAMED SRN: CN-MF-000013859
Authorised representative: Medten EU ApS DK-AR-000034434

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Properties

Reusable
Measuring Function

Other properties (11)

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