Delcath Systems Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000017723 FEI 3008822486
- Devices
- 9
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
Catalogue
Chemosat Ref 602019-03
Regimes: CE MDR Registry: EUDAMEDChemosat Ref 602019-04
Regimes: CE MDR Registry: EUDAMEDChemosat Ref 602001-01
Regimes: CE MDR Registry: EUDAMEDChemosat Ref 602018-01
Regimes: CE MDR Registry: EUDAMEDChemosat Ref 602018-02
Regimes: CE MDR Registry: EUDAMEDChemosat Ref 602018-04
Regimes: CE MDR Registry: EUDAMEDChemosat Ref 602019-01
Regimes: CE MDR Registry: EUDAMEDChemosat Ref 602019-02
Regimes: CE MDR Registry: EUDAMEDChemosat Ref 602018-03
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000017723
- FDA FEI number
- 3008822486
- EUDAMED status
- Active
- EUDAMED registered name
- Delcath Systems Inc.
- Registered address
- 566, Queensbury Ave, 12804, Queensbury, United States
- Website
- www.chemosat.com
- [email protected]
- Phone
- +1 518 743 8892
- PRRC contact
- Kent Vickerman
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 27 Feb 2027
Notified body 2797 1 certificate
- MDR 732543 Expiring
Technical documentation EU MDR
- Issued
- 25 Sep 2026
- Expires
- 27 Feb 2027
- Reason
- Ar data change
From the company website
Delcath are the manufacturers of CHEMOSAT and have over 12 years' experience in the European market. We are committed to improving the lives of patients with primary and metastatic liver cancer. Our in-house clinical team continues to focus on areas such as metastatic uveal melanoma (mUM), intrahepatic cholangiocarcinoma (ICC) & colorectal cancer (CRC)
Frequently asked questions
How many devices does Delcath Systems Inc. have in the registry?
The registry currently lists 9 devices for Delcath Systems Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Delcath Systems Inc.'s devices?
Among its 9 most recently registered devices, Delcath Systems Inc. has devices listed in EUDAMED (9 devices).
What risk classes do Delcath Systems Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Delcath Systems Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Delcath Systems Inc.?
EUDAMED lists 1 certificate for Delcath Systems Inc. (technical documentation) under MDR. The most recent was issued on 2026-09-25.
What are the newest devices from Delcath Systems Inc. in the registry?
The most recently registered devices listed for Delcath Systems Inc. include CHEMOSAT.