FIZE Medical Ltd.
Active in EUDAMEDIsraelfrom SRN EUDAMED FDA SRN IL-MF-000046483 FEI 3021192255
- Devices
- 6
- 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
FIZE kUO console 2.4G with power supply EU Ref FKUO2.4G_PS_EU
CE MDR EUDAMEDFIZE Disposable, Adults, 10EA Ref FI-FG00-KU03-0003
CE MDR EUDAMEDFIZE kUO console 5G with power supply EU Ref FKUO5.0G_PS_EU
CE MDR EUDAMEDFIZE kUO console 2.4G with power box EU Ref FKUO2.4G_PB_EU
CE MDR EUDAMEDFIZE Disposable- Pediatrics, 10EA Ref FI-FG00-KU03-0004
CE MDR EUDAMEDFIZE kUO console 5G with power box EU Ref FKUO5.0G_PB_EU
CE MDR EUDAMED
Company details
- EUDAMED SRN
- IL-MF-000046483
- FDA FEI number
- 3021192255
- EU VAT number
- 514606342
- EUDAMED status
- Active
- EUDAMED registered name
- FIZE Medical Ltd.
- EUDAMED abbreviated name
- FIZE
- Registered address
- 15, Hashdera Hamerkazit, 7173004, Modi'in-Macabim-Re'ut, Israel
- Website
- www.fizemedical.com
- [email protected]
- Phone
- +972547791693
- PRRC contact
- Yael Goldbrener
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 8 Jul 2031
Notified body 2797 1 certificate
- MDR 792769 Issued
Quality management system EU MDR
- Issued
- 9 Jul 2026
- Expires
- 8 Jul 2031
From the company website
FIZE Medical offers the first platform technology to remotely monitor and manage patients with an indwelling Foley catheter. Learn more about us >>
Frequently asked questions
How many devices does FIZE Medical Ltd. have in the registry?
The registry currently lists 6 devices for FIZE Medical Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list FIZE Medical Ltd.'s devices?
Among its 6 most recently registered devices, FIZE Medical Ltd. has devices listed in EUDAMED (6 devices).
What risk classes do FIZE Medical Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for FIZE Medical Ltd.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for FIZE Medical Ltd.?
EUDAMED lists 1 certificate for FIZE Medical Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-07-09.
What are the newest devices from FIZE Medical Ltd. in the registry?
The most recently registered devices listed for FIZE Medical Ltd. include FIZE kUO console 2.4G with power supply EU, FIZE Disposable, Adults, 10EA, FIZE kUO console 5G with power supply EU and FIZE kUO console 2.4G with power box EU.