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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

DuraSheath Introducer Sheath System — Class III MDR

MD Atlas
Contract Medical International GmbH

EUDAMED last updated this device on May 7, 2026

DuraSheath Introducer Sheath System

4251244500000013C

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Contract Medical International GmbH
UDI-DI code: 04251244502867
Reference / catalog number: FG-05015

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View device family (Basic UDI)

Manufacturer information

Organization name: Contract Medical International GmbH
SRN: DE-MF-000007409
Manufacturer status: Active

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DuraSheath Introducer Sheath System4251244500000013COn the market Fortress®B-04251244500566On the market VS18100B-04251244500382On the market VS18060B-04251244500399On the market VS12100B-04251244500405On the market

Certificates

Certificate health across this manufacturer's portfolio.

2254506TD01Supplemented
Technical documentationNotified body: 0344Expiry: Jun 1, 2027
2254506CE02Issued
Quality management systemNotified body: 0344Expiry: Jun 1, 2027
2254506CE01Issued
Quality management systemNotified body: 0344Expiry: Jun 1, 2027

Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW999
Sterile using ethylene oxide[
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW011
See instructions for use before use
CW009
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: DuraSheath Introducer Sheath System
UDI-DI code: 04251244502867
Basic UDI-DI: 4251244500000013C
Reference / catalog number: FG-05015
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the human vasculature, including but not limited to femoral access.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Straight
5 MU170
1.92 MU50
15 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

C0502CARDIOVASCULAR INTRODUCER SHEATHS, VALVED

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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