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DuraSheath Introducer Sheath System

EUDAMED

Class III (EU MDR)

Ref FG-05090-F-MPRef FG-06045-F-MPRef FG-05045-F-HSRef FG-05045-F-MPRef FG-06090-F-MPRef FG-07045-F-LIMARef FG-07015Ref FG-05045-F-LIMARef FG-06045-F-LIMARef FG-07090Ref FG-05060-F-HSRef FG-08090Ref FG-05090Ref FG-05015-FRef FG-06090-FRef FG-07045-F-RDCRef FG-05060-F-RDCRef FG-05045Ref FG-04015 Ref FG-05045-FRef FG-05060-F-LIMARef FG-07060Ref FG-04045Ref FG-07045Ref FG-06045-FRef FG-06090-F-RDCRef FG-05090-F-HSRef FG-06060-F-RDCRef FG-07090-F-MPRef FG-06060-F-HSRef FG-08015Ref FG-07045-F-HSRef FG-07060-F-MPRef FG-04090Ref FG-04090-FRef FG-05045-F-RDCRef FG-06060Ref FG-06015Ref FG-05015Ref FG-06090Ref FG-07090-FRef FG-06060-FRef FG-06060-F-LIMARef FG-06045-F-RDC Ref FG-08060

by Contract Medical International GmbH

Identity

Trade Name
DuraSheath Introducer Sheath System EUDAMED
Device Name
DuraSheath Introducer Sheath System EUDAMED
Model / Reference
FG-05090-F-MP EUDAMED
FG-06045-F-MP EUDAMED
FG-05045-F-HS EUDAMED
FG-05045-F-MP EUDAMED
FG-06090-F-MP EUDAMED
FG-07045-F-LIMA EUDAMED
FG-07015 EUDAMED
FG-05045-F-LIMA EUDAMED
FG-06045-F-LIMA EUDAMED
FG-07090 EUDAMED
FG-05060-F-HS EUDAMED
FG-08090 EUDAMED
FG-05090 EUDAMED
FG-05015-F EUDAMED
FG-06090-F EUDAMED
FG-07045-F-RDC EUDAMED
FG-05060-F-RDC EUDAMED
FG-05045 EUDAMED
FG-04015 EUDAMED
FG-05045-F EUDAMED
FG-05060-F-LIMA EUDAMED
FG-07060 EUDAMED
FG-04045 EUDAMED
FG-07045 EUDAMED
FG-06045-F EUDAMED
FG-06090-F-RDC EUDAMED
FG-05090-F-HS EUDAMED
FG-06060-F-RDC EUDAMED
FG-07090-F-MP EUDAMED
FG-06060-F-HS EUDAMED
FG-08015 EUDAMED
FG-07045-F-HS EUDAMED
FG-07060-F-MP EUDAMED
FG-04090 EUDAMED
FG-04090-F EUDAMED
FG-05045-F-RDC EUDAMED
FG-06060 EUDAMED
FG-06015 EUDAMED
FG-05015 EUDAMED
FG-06090 EUDAMED
FG-07090-F EUDAMED
FG-06060-F EUDAMED
FG-06060-F-LIMA EUDAMED
FG-06045-F-RDC EUDAMED
FG-08060 EUDAMED

Identifiers

Primary DI / UDI-DI
04251244501129 EUDAMED
04251244501280 EUDAMED
04251244501310 EUDAMED
04251244501327 EUDAMED
04251244501013 EUDAMED
04251244501228 EUDAMED
04251244501341 EUDAMED
04251244501303 EUDAMED
04251244501266 EUDAMED
04251244502973 EUDAMED
04251244503154 EUDAMED
04251244503215 EUDAMED
04251244503017 EUDAMED
04251244502898 EUDAMED
04251244502942 EUDAMED
04251244503079 EUDAMED
04251244503345 EUDAMED
04251244503116 EUDAMED
04251244503451 EUDAMED
04251244503178 EUDAMED
04251244502874 EUDAMED
04251244502829 EUDAMED
04251244503086 EUDAMED
04251244503147 EUDAMED
04251244502966 EUDAMED
04251244502836 EUDAMED
04251244502959 EUDAMED
04251244503246 EUDAMED
04251244503390 EUDAMED
04251244503208 EUDAMED
04251244503338 EUDAMED
04251244503543 EUDAMED
04251244503314 EUDAMED
04251244502980 EUDAMED
04251244503437 EUDAMED
04251244503499 EUDAMED
04251244502850 EUDAMED
04251244503055 EUDAMED
04251244503123 EUDAMED
04251244503277 EUDAMED
04251244502928 EUDAMED
04251244502904 EUDAMED
04251244502867 EUDAMED
04251244502935 EUDAMED
04251244503512 EUDAMED
04251244503291 EUDAMED
04251244503307 EUDAMED
04251244503284 EUDAMED
04251244503000 EUDAMED
Basic UDI-DI
4251244500000013C EUDAMED
EMDN Code
C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED

Classification

Device Class
Class III EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Vascular catheter introduction set, nonimplantable

DuraSheath Introducer Sheath System by Contract Medical International GmbH — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Contract Medical International GmbH
EUDAMED SRN
DE-MF-000007409

Sources (49)

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  • EUDAMED 2412db3f-e054-44b4-b0d8-4983c854bb36 61 fields · synced Sep 18, 2026