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FSP848-313815 Thoracic suction controller on a direct BS vacuum probe, collection jar on a universal rail clamp

by Gabler Medical (Pty) Ltd EUDAMED

Active European Union

Ref FSP848-313815Model Suction Equipment Powered by a Pressure Source

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6009526100007GMTF02RB Basic UDI-DIDate1 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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

Specification

EUDAMED

Device Name
Suction Equipment Powered by a Pressure Source
Model / Reference
Suction Equipment Powered by a Pressure Source, FSP848-313815
Primary DI / UDI-DI
06009526136563
Basic UDI-DI
6009526100007GMTF02RB
EMDN Code
A0601010201 Drainage systems with adjustable suction and collection chamber
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
ZA-MF-000046864
Authorised representative
Advena Limited MT-AR-000000234

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Properties

Other properties (13)

  • 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
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No