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EXTesia

by Curatia Medical Limited 550 variants

Ref 2IS050538SJN

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 24 Oct 2026. What this means

Overview

Introducing the EXTesia Introducer Sheath Set, a precision medical device designed for safe and effective suturing. Engineered with advanced technology, this set provides unparalleled control and visualization, making it ideal for a wide range of surgical applications.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697022652107FS Basic UDI-DI 06941358009397UDI-DIDate10 Apr 2026RegisteredStatusActive

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

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
2IS050538SJN
Primary DI / UDI-DI
06941358009397
Basic UDI-DI
697022652107FS
EMDN Code
C0504 Arterial introduction sets
Device Class
Class IIa
EU market of registration
Estonia

Manufacturer details

EUDAMED SRN
CN-MF-000015976
Authorised representative
MedNet EC-REP III GmbH DE-AR-000011191

Related devices

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

Other devices from Curatia Medical Limited

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Properties

  • Sterile

Other properties (12)

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