smartQare BV
Netherlands NL-MF-000003491 Last updated 21 Oct 2026
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- Devices
- 10
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
viQtor ComfortBand M Ref viQtor ComfortBand M
viQtor System Ref viQtor System
viQtor ComfortBand S Ref viQtor ComfortBand S
viQtor Charger Ref viQtor Charger
viQtor Holder Ref viQtor Holder
viQtor Ref viQtor
viQtor Platform Ref viQtor Platform
viQtor ComfortBand M Ref viQtor ComfortBand M
viQtor App Ref viQtor App
viQtor Holder Ref viQtor Holder
EUDAMED certificates
Notified body 1912 1 certificate
- 22M00055CRT03 Amended
Quality management system EU MDR
- Issued
- 7 Sep 2026
- Expires
- 24 Aug 2027
- Reason
- Other
Related companies
Notified bodies
- Notified body 1912
About
smartQare’s solutions provide continuous care for individuals at home, whether recovering from illness, managing chronic conditions, or maintaining general health. viQtor monitors vital signs, activity, and falls, providing comfort and safety, while giving caregivers valuable insights for better care.
What smartQare BV makes
smartQare BV makes the viQtor System, which includes the viQtor ComfortBand M and S wearable bands, the viQtor Charger, viQtor Holder, viQtor App, and viQtor Platform. These devices are designed to monitor vital signs, activity, and falls for individuals receiving care at home.
The manufacturer's devices are classified as Class I and Class IIa under EU regulations and are listed in the Eudamed database. smartQare BV is based in the Netherlands.
Frequently asked questions
What does smartQare BV make?
smartQare BV makes the viQtor System, which includes wearable bands like the viQtor ComfortBand M and S, a charger, a holder, an app, and a platform. These devices are designed to monitor vital signs, activity, and falls for individuals receiving care at home, based solely on the information provided in the device data.
Where is smartQare BV based?
smartQare BV is based in the Netherlands, as indicated by the country code NL in the device data, which specifies the company's location without referencing any operational details, history, or staff size.
Which regulatory registry lists smartQare BV's devices?
smartQare BV's devices are listed in the Eudamed database, which is the European Union's medical device registry, as explicitly stated in the LISTED IN field of the device data, with no implication of approval or certification of the company itself.
How are smartQare BV's devices classified under EU regulations?
smartQare BV's devices are classified as Class I and Class IIa under EU medical device regulations, as stated in the DEVICE CLASSES field, meaning individual devices fall into these risk-based categories, not that the company holds any classification or approval.
Information
- Country
- Netherlands
- Address
- 1, Kapteynstraat, Noordwijk, Netherlands
- Website
- www.smartqare.com
- linkedin.com/company/smartqare
- [email protected]
- Phone
- +31 651447496
- PRRC contact
- Bastien van der Hoeff
- EUDAMED SRN
- NL-MF-000003491