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ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) for 17 mm Vial

by Epic International (Thailand) Co., Ltd. EUDAMED

Active European Union

Ref 420900

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88592991B014UD Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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

Specification

EUDAMED

Device Name
CSTD and Administration Devices
Model / Reference
420900
Primary DI / UDI-DI
18859299130900
Basic UDI-DI
88592991B014UD
EMDN Code
A0704 Systems for reconstitution and administration of pharmaceuticals
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
TH-MF-000012102
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

From the manufacturer

Manufacturer's product page: ToxiSeal Vial Adapter

Other devices from Epic International (Thailand) Co., Ltd.

See all devices from Epic International (Thailand) Co., Ltd. →

Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No