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ToxiSeal Vial Adaptor with External Flip Balloon 420730

by Epic International(Thailand) Company Limited

Ref 420730

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number18859299130733 UDI-DI Date4 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88592991B014UD Basic UDI-DI 18859299130733UDI-DIDate25 May 2026RegisteredStatusActive EUDAMED: not on the EU market

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 20 mm Vial Concave EUDAMED
ToxiSeal Vial Adaptor with External Flip Balloon GUDID
Generic Name
Vial/bottle adaptor, hermetic
Device Name
CSTD and Administration Devices
Model / Reference
420730
Primary DI / UDI-DI
18859299130733
Basic UDI-DI
88592991B014UD
510(k) Number
FDA Product Code
ONB
EMDN Code
A0704 Systems for reconstitution and administration of pharmaceuticals
GMDN Term
Vial/bottle adaptor, hermetic
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5440
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K241476)

Other devices from Epic International(Thailand) Company Limited

See all devices from Epic International(Thailand) Company Limited →

Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No