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Loremed®

by SML Med-Tech Solutions Limited China EUDAMED

Ref SML003-FJ01Model SML003-FJ EMDN G0380

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number489712999SML003UZ Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Disposable Endoscope Valve Sets
Model / Reference
SML003-FJ, SML003-FJ01
Primary DI / UDI-DI
04897129991649
Basic UDI-DI
489712999SML003UZ
EMDN Code
G0380 Digestive endoscopy devices - accessories
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000031313
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from SML Med-Tech Solutions Limited

See all devices from SML Med-Tech Solutions Limited →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 04897129991649|489712999SML003UZ 61 fields · synced 25 Oct 2026