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IST Set 8E+ Portnadelwechsel

by IST Medical GmbH

Ref 101037Model IST Set 8E+ Portnadelwechsel

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EIST101037KB Basic UDI-DI +EIST1010370DUDI-DIDate19 Oct 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  • Withdrawn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
IST Set 8E+ Portnadelwechsel, 101037
Primary DI / UDI-DI
+EIST1010370D
Basic UDI-DI
++EIST101037KB
EMDN Code
A01010301 Needles and kits for implantable systems (port), with safety systems
Device Class
Class I
Medical Purpose
System für Portnadelwechsel ohne Nadel

Manufacturer details

EUDAMED SRN
DE-PR-000021824

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Properties

  • Sterile