Galaxy Therapeutics, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000035675 FEI 3022418643
- Devices
- 15
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
Catalogue
Search and filter all 15 devicesCompany details
- EUDAMED SRN
- US-MF-000035675
- FDA FEI number
- 3022418643
- EUDAMED status
- Active
- EUDAMED registered name
- Galaxy Therapeutics, Inc.
- Registered address
- 803, Ames Ave., CA 95035, Milpitas, California, United States
- Website
- galaxytherapeutics.com/
- [email protected]
- PRRC contact
- Jim Twitchell
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 28 Jul 2031
DQS Medizinprodukte GmbH 0297 2 certificates
- 1000269457 Active
Quality management system EU MDR
- Issued
- 29 Jul 2026
- Expires
- 28 Jul 2031
- 1000322051 Active
Technical documentation EU MDR
- Issued
- 29 Jul 2026
- Expires
- 28 Jul 2031
From the company website
Galaxy Therapeutics is a clinical-phase startup founded and led by a group of seasoned neurointerventionalists dedicated to streamlining intrasaccular flow diversion. Supported by a team of accomplished engineers and neurovascular experts, we relentlessly pursue the transformation of patients’ lives.
Frequently asked questions
How many devices does Galaxy Therapeutics, Inc. have in the registry?
The registry currently lists 15 devices for Galaxy Therapeutics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Galaxy Therapeutics, Inc.'s devices?
Among its 15 most recently registered devices, Galaxy Therapeutics, Inc. has devices listed in EUDAMED (15 devices).
What risk classes do Galaxy Therapeutics, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Galaxy Therapeutics, Inc.'s devices are Class IIa and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Galaxy Therapeutics, Inc.?
EUDAMED lists 2 certificates for Galaxy Therapeutics, Inc. (quality management system; technical documentation) under MDR. 2 are recorded with the status issued. The most recent was issued on 29 Jul 2026.
What are the newest devices from Galaxy Therapeutics, Inc. in the registry?
The most recently registered devices listed for Galaxy Therapeutics, Inc. include SEAL™ Detachment Handle, SEAL™ ARC and SEAL™ Base.