FastFocus B.V.
Active in EUDAMEDNetherlandsfrom SRN EUDAMED SRN NL-MF-000002981
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What FastFocus B.V. makes
FastFocus B.V. manufactures a Vital Signs Monitoring System designed to track oxygen saturation, pulse rate, breathing frequency, physical activity, posture, and motion intensity. The device is intended for continuous monitoring of adult patients to detect early signs of decline, supporting clinical assessment in care settings.
The Vital Signs Monitoring System is classified as a Class IIa medical device and is listed in the EU’s eudamed registry. The company is based in the Netherlands.
Catalogue
Vital Signs Monitoring System Ref 1200
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- NL-MF-000002981
- EUDAMED status
- Active
- EUDAMED registered name
- FastFocus B.V.
- EUDAMED abbreviated name
- FastFocus
- Registered address
- 9, Gerverscop, 3481 LT, Harmelen, Netherlands
- Website
- www.fastfocus.nl/
- [email protected]
- Phone
- +31850061121
- PRRC contact
- Natasha Pasricha
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 29 Jun 2028
Notified body 1912 1 certificate
- 21M00096SUP03 Active
Quality management system EU MDR
- Issued
- 7 Oct 2026
- Expires
- 29 Jun 2028
- Reason
- Other
From the company website
The FastFocus Vital Signs Monitoring System monitors oxygen saturation, pulse, breathing frequency, physical activity, posture and motion intensity. It detects early decline in adult patients, making it a valuable tool for care professionals.
Frequently asked questions
How many devices does FastFocus B.V. have in the registry?
The registry currently lists 1 device for FastFocus B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list FastFocus B.V.'s devices?
Among its 1 most recently registered device, FastFocus B.V. has devices listed in EUDAMED (1 device).
What risk classes do FastFocus B.V.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for FastFocus B.V.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for FastFocus B.V.?
EUDAMED lists 1 certificate for FastFocus B.V. (quality management system) under MDR. The most recent was issued on 2026-10-07.
What are the newest devices from FastFocus B.V. in the registry?
The most recently registered devices listed for FastFocus B.V. include Vital Signs Monitoring System.