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Barrier Film/Sleeves

by Wellmed Dental Medical Supply Co., Ltd EUDAMED

Active European Union

Ref PET-002/0188Model 002/0188

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697460865002/0188RE Basic UDI-DIDate13 May 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  • Withdrawn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

Device Name
Barrier Film/Sleeves
Model / Reference
002/0188, PET-002/0188
Primary DI / UDI-DI
05060660615070
Basic UDI-DI
697460865002/0188RE
EMDN Code
T030102 Cover sheaths, instruments and equipments
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000003243
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wellmed Dental Medical Supply Co., Ltd

See all devices from Wellmed Dental Medical Supply Co., Ltd →

Properties

Show 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