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Saf-T-Intima

by Becton Dickinson Infusion Therapy Systems Inc. 7 variants

Ref 383328

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 Number038290ESLWZLJRKH Basic UDI-DI 00382903833283UDI-DIDate29 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  • Withdrawn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

Device Name
BD Saf-T-Intima™ Safety System
Model / Reference
383328
Primary DI / UDI-DI
00382903833283
Basic UDI-DI
038290ESLWZLJRKH
EMDN Code
C01010103 Peripheral i.v. catheters, with integrated extensions
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
US-MF-000017719
Authorised representative
Becton Dickinson Ireland Limited IE-AR-000007610

Other devices from Becton Dickinson Infusion Therapy Systems Inc.

See all devices from Becton Dickinson Infusion Therapy Systems Inc. →

Properties

  • Sterile
  • CMR Substance
  • Animal Tissues

Other properties (10)

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