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Seal™ Arc

by Galaxy Therapeutics, Inc. 7 variants

Ref FG0007-03E

Active European Union

CE MDR

Valid until

28 Jul 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

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 Number1000269457 Date29 Jul 2026IssuedStatusActive expires 28 Jul 2031

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000269457 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    29 Jul 2026
    Expires
    28 Jul 2031
  • 1000322051 Active

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    29 Jul 2026
    Expires
    28 Jul 2031

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Map note: Northern Ireland has no dot of its own.

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Specification

EUDAMED

Device Name
SEAL™ Embolization System
Model / Reference
FG0007-03E
Primary DI / UDI-DI
00850052512255
Basic UDI-DI
0850052512SEALSV
EMDN Code
C01050299 Intravascular embolic protection catheters and systems - other
Device Class
Class III
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000035675
Authorised representative
Specculo Limited MT-AR-000034988

Other devices from Galaxy Therapeutics, Inc.

See all devices from Galaxy Therapeutics, Inc. →

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