Disposable Introducer Set

by Ortus Medi-Tech Co., Ltd 27 variants

Ref OM-IS09-02

Active European Union

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-06972985352013 Basic UDI-DI 06972985352013UDI-DI	Date7 Aug 2024Registered	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Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference: OM-IS09-02

Primary DI / UDI-DI: 06972985352013
Basic UDI-DI: B-06972985352013
EMDN Code: C0504 Arterial introduction sets

Device Class: Class IIa
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: CN-MF-000031033
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Ortus Medi-Tech Co., Ltd

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Disposable Manifold

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Disposable Angiography Syringes without needle

Class I
Disposable Introducer Set

Class IIa
Disposable Guide Wire

Class IIa

See all devices from Ortus Medi-Tech Co., Ltd →

Properties

Sterile

Other properties (10)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No