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Lt

by SMART Medical Systems Ltd. 4 variants

Ref 32-035Model Leak Tester Main

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7290018671LTGS Basic UDI-DI 07290018671580UDI-DIDate25 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Leak Tester
Model / Reference
Leak Tester Main, 32-035
Primary DI / UDI-DI
07290018671580
Basic UDI-DI
7290018671LTGS
Direct Marketing DI
07290018671580
EMDN Code
G0380 Digestive endoscopy devices - accessories
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IL-MF-000011336
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Related devices

Category: Gastro-urological guidewire, single-use

Other devices from Smart Medical Systems Ltd

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Properties

Other properties (13)

  • Sterile: No
  • 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