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Disposable Introducer Set

EUDAMED

Class IIa (EU MDR)

Ref OM-IS05-03Ref OM-IS08-01

by Ortus Medi-Tech Co., Ltd

Identity

Trade Name
Disposable Introducer Set EUDAMED
Device Name
Disposable Introducer Set EUDAMED
Model / Reference
OM-IS05-03 EUDAMED
OM-IS08-01 EUDAMED

Identifiers

Primary DI / UDI-DI
06972985350897 EUDAMED
06972985350972 EUDAMED
Basic UDI-DI
B-06972985350897 EUDAMED
B-06972985350972 EUDAMED
EMDN Code
C0504 ARTERIAL INTRODUCTION SETS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Interventional radiology percutaneous-access kit, single-use

Disposable Introducer Set by Ortus Medi-Tech Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Interventional radiology percutaneous-access kit, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Ortus Medi-Tech Co., Ltd
EUDAMED SRN
CN-MF-000031033
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 00b24ded-024f-4a5e-94a2-931b7c3651e6 61 fields · synced Jul 29, 2026
  • EUDAMED 28729414-dc10-4c0c-b2c0-41332f2ee7b3 61 fields · synced May 18, 2026