SPD Swiss Precision Diagnostics GmbH
CH-MF-000025175 · Switzerland · Petit-Lancy
SPD Swiss Precision Diagnostics GmbH is registered in the European database on medical devices as a manufacturer, with 190 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: ADOT, ADOT/CB11, CB11/CB11A, CB14, CB14/CB9A.
Authorised representative in the Union: MDSS GmbH.
Devices declared under this manufacturer
- Advanced Fertilitätsmonitor Teststäbchen
- Clearblue Prueba de embarazo Ultratemprana
- Clearblue Schwangerschaftstest Ultra Frühtest
- Clearblue Schwangerschaftstest Ultra Frühtest FORTSCHRITTLICH
- Clearblue Schwangerschaftstest mit Wochenbestimmung
- Clearblue Test de grossesse Ultra Précoce Digitale
- Clearblue Test de grossesse avec Estimation de l’âge de la grossesse
- Clearblue Zwangerschapstest Ultravroeg
- Eggløsningstest Advanced Digital
- Fertility Monitor Advanced
- Ovulationstest Fortschrittlich & Digital
- Ovulationstest Fortschrittlich & Digital + Schwangerschaftstest Schnel
Showing 12 of 190 declared devices.
Catalogue references include 04015600522315, 04015600997571, 05013965856051, 08001841913377, 08006530454292, 08006530600934.
European nomenclature codes declared: W0102160302, W0102160304, W0102160302,W0102160304.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SPD SWISS PRECISION DIAGNOSTICS GMBH (CH) · FDA 3006635320 |
| Devices in EUDAMED | 190 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 190 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SPD SWISS PRECISION DIAGNOSTICS GMBH |
What it holds in Canada
| Licences on record | 12 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 12 |
| First licensed | 1999-07-07 |
Licence types: Test Kit (11), System (1).
Licensed under: CLEARBLUE OVULATION TEST EASY, CLEARBLUE OVULATION TEST DIGITAL, CLEARBLUE PREGNANCY TEST WITH WEEKS INDICATOR, CLEARBLUE PREGNANCY TEST RAPID DETECTION, CLEARBLUE PREGNANCY TESTS RAPID & WEEKS INDICA, CLEARBLUE OVULATION TEST ADVANCED DIGITAL.
North American profile: Both markets. SPD Swiss Precision Diagnostics GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V76 099371 0033 | issued | 2031-06-17 |
V76 099371 0032 | issued | 2031-06-21 |
V76 099371 0031 | issued | 2030-11-03 |
V76 099371 0030 | supplemented | 2030-10-27 |
V74 099371 0023 | supplemented | 2030-02-18 |
V74 099371 0022 | supplemented | 2030-02-25 |
V74 099371 0018 | issued | 2030-01-28 |
V74 099371 0016 | issued | 2029-07-31 |