Skip to content

Aquabrid

by Sanyo Chemical Industries Ltd. EUDAMED

Active European Union

Ref MAB2G-01

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number45805141800000000000001GH Basic UDI-DIDate24 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 4202520CE01 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    28 May 2024
    Expires
    24 Mar 2028
  • 4202520TD01 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    28 May 2024
    Expires
    24 Mar 2028

Specification

EUDAMED

Device Name
AQUABRID Surgical Sealant
Model / Reference
MAB2G-01
Primary DI / UDI-DI
04580514180017
Basic UDI-DI
45805141800000000000001GH
EMDN Code
H90010102 Synthetic glues
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000001762
Authorised representative
TERUMO EUROPE N.V. BE-AR-000001433

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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