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SEAL™ Detachment Handle

by Galaxy Therapeutics, Inc.

Ref FG0011EModel SEAL™ Detachment Handle

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850052512HANDLEPP Basic UDI-DI 00850052512156UDI-DIDate10 Oct 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  • Withdrawn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

Model / Reference
SEAL™ Detachment Handle, FG0011E
Primary DI / UDI-DI
00850052512156
Basic UDI-DI
0850052512HANDLEPP
EMDN Code
C010580 Intravascular protection devices - accessories
Device Class
Class IIa
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.

  • Seal™ Arc

    Class III

  • SEAL™ Base

    Class III

  • Seal™ Arc

    Class III

  • Seal™ Arc

    Class III

  • Seal™ Arc

    Class III

  • Seal™ Arc

    Class III

See all devices from Galaxy Therapeutics, Inc. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • 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