Unknown / Not in EUDAMED

Snapshot 2026-10-27 · Link to EUDAMED

CHEMOSAT

UDI-DI 00850014023201Basic UDI-DI 0850014023CHEMOSAT-HDSXQ

Class III · MDR · Delcath Systems Inc.

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Identification

Model: 602001-01
EMDN: C019013
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR 732543

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-09-25 · Expiry 2027-02-27

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Delcath Systems Inc.

SRN US-MF-000017723

US · Queensbury

manufacturer

Authorised representative: Delcath Systems Ltd (IE-AR-000017370)

Related UDI-DIs

CHEMOSAT 00850014023249
CHEMOSAT 00850014023003
CHEMOSAT 00850014023188
CHEMOSAT 00850014023256
CHEMOSAT 00850014023218
CHEMOSAT 00850014023195
CHEMOSAT 00850014023232
CHEMOSAT 00850014023225

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/chemosat-3201 · UDI page: /udi/00850014023201

All devices from Delcath Systems Inc.

Scan an inventory CSV