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Chemosat

by Delcath Systems Inc. 9 variants

Ref 602001-01

Expiring European Union

CE MDR

Valid until

27 Feb 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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 NumberMDR 732543 Date25 Sep 2026IssuedStatusExpiring expires 27 Feb 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 732543 Expiring Amended Expires in 121 days

    Technical documentation EU MDR

    Notified body
    BSI Group The Netherlands B.V. 2797
    Issued
    25 Sep 2026
    Expires
    27 Feb 2027
    Reason
    Ar data change

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
CHEMOSAT Hepatic Delivery System
Model / Reference
602001-01
Primary DI / UDI-DI
00850014023003
Basic UDI-DI
0850014023CHEMOSAT-HDSXQ
EMDN Code
C019013 Isolated tissue perfusion systems (locoregional tumor therapy)
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000017723
Authorised representative
Delcath Systems Ltd IE-AR-000017370

Other devices from Delcath Systems Inc.

  • Chemosat

    Class III

  • Chemosat

    Class III

  • Chemosat

    Class III

  • Chemosat

    Class III

  • Chemosat

    Class III

  • Chemosat

    Class III

See all devices from Delcath Systems Inc. →

Properties

  • Sterile
  • Contains Latex
  • Administering Medicine

Other properties (10)

  • Implantable: No
  • Reusable: 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