smartQare BV
NL-MF-000003491 · Netherlands · Noordwijk
smartQare BV is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 11 |
|---|
Most frequent device types declared: viQtor Charger.
Among these devices, 5 are declared active, 4 with a measuring function.
Devices declared under this manufacturer
- viQtor
- viQtor App
- viQtor Charger
- viQtor ComfortBand L
- viQtor ComfortBand M
- viQtor ComfortBand S
- viQtor Holder
- viQtor Platform
- viQtor System
Catalogue references include viQtor, viQtor App, viQtor Charger, viQtor ComfortBand L, viQtor ComfortBand M, viQtor ComfortBand S.
European nomenclature codes declared: Z12030280, Z1203020202, Z1203020292, Z12030201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 11 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. smartQare BV was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
22M00055CRT01 | issued | 2027-08-24 |