Skip to content

ProSeal Non-Vented Bag Spike with ProSeal Injection Site (DMA Compatible)

by Epic International (Thailand) Co., Ltd. 6 variants

Ref 423845

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88592991B014UD Basic UDI-DI 58859299133848UDI-DIDate25 May 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
CSTD and Administration Devices
Model / Reference
423845
Primary DI / UDI-DI
58859299133848
Basic UDI-DI
88592991B014UD
Unit of Use DI
48859299133841
EMDN Code
A070103 Infusion tubing adapters and connectors
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

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

From the manufacturer

Manufacturer's product page: ProSeal™

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