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Mk-Fss-2Y

by GBUK Group

Ref MK-FSS-2YModel MK-FSRA-12

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, self-declared

Class I: no certifier involved

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 Number506059088ISOSAFFS8J Basic UDI-DIDate13 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
MK-FSRA-12, MK-FSS-2Y
Primary DI / UDI-DI
05060999351533
Basic UDI-DI
506059088ISOSAFFS8J
EMDN Code
G02020201 Gastrostomy, tubes and sets
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000002238
Authorised representative
Qualrep Services B.V. NL-AR-000000537

Other devices from GBUK Group, Ltd.

See all devices from GBUK Group, Ltd. →

Properties

  • Administering Medicine

Other properties (12)

  • Sterile: No
  • 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