Ivwatch, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000001531 FEI 3011490091
- Devices
- 14
- 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
- Authorised rep.
- Emergo Europe B.V.NL
Catalogue
Search and filter all 14 devicesCompany details
- EUDAMED SRN
- US-MF-000001531
- FDA FEI number
- 3011490091
- DUNS number
- 057028415
- EUDAMED status
- Active
- EUDAMED registered name
- ivWatch, LLC
- Registered address
- 700, Tech Center Parkway, 23606, Newport News, United States
- Website
- www.ivwatch.com
- [email protected]
- Phone
- 18554892824
- PRRC contact
- Holly Novak
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 27 Feb 2030
TÜV SÜD Product Service GmbH 0123 1 certificate
- G10 095360 0020 Active
Quality management system EU MDR
- Issued
- 28 Feb 2025
- Expires
- 27 Feb 2030
Frequently asked questions
How many devices does IVWATCH, LLC have in the registry?
The registry currently lists 14 devices for IVWATCH, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list IVWATCH, LLC's devices?
Among its 14 most recently registered devices, IVWATCH, LLC has devices listed in EUDAMED (7 devices), FDA 510(k) (1 device) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do IVWATCH, LLC's devices fall under?
Among its 14 most recently registered devices, the classes recorded for IVWATCH, LLC's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for IVWATCH, LLC?
EUDAMED lists 1 certificate for IVWATCH, LLC (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 28 Feb 2025.
What are the newest devices from IVWATCH, LLC in the registry?
The most recently registered devices listed for IVWATCH, LLC include ivWatch Patient Monitor Model 400, ivWatch SmartTouch Sensor Model 400, ivWatch Sensor Receptacle Model 400 and blox BLX-9501.