Compumedics Germany GmbH
DE-MF-000005586 · Germany · Singen
Compumedics Germany GmbH is registered in the European database on medical devices as a manufacturer, with 47 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 47 |
|---|
Most frequent device types declared: 16 MHz Probe 2 mm, 16 MHz Probe 3mm, 16 MHz Probes, Doppler BoxX, EZ-Dop Series.
Among these devices, 47 are declared active.
Devices declared under this manufacturer
- 1-MHz-Probe (2,9 Meter Cable)
- 16 MHz Probe Ø 1 mm (flexible cable, 2.5 m)
- 16 MHz Probe Ø 2 mm (flexible cable, 2.5 m)
- 16 MHz Probe Ø 3 mm (flexibel cable, 2.5 m)
- 2 MHz Probe MRSafe, click&stay, orange labeling, 5 m)
- 2 MHz Sonde, click&stay, right side, green labeling
- 2-MHz-Probe (2 Meter Cabel)
- 2-MHz-Probe (2,9 Meter Cabel)
- 4 MHz Probe, click&stay, left side, orange labeling
- 4 MHz Probe, screwed, right side, green labeling
- 4-MHz-Probe (2 Meter Cabel)
- 4-MHz-Probe (2,9 Meter Cabel)
Showing 12 of 47 declared devices.
Catalogue references include 3655, 6027, 6031_1, 6048, 6991_1, 8000.
European nomenclature codes declared: Z11040299, Z12040111, L1699, Z110402010101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Compumedics Germany GmbH (DE) · FDA 3004752776 |
| Devices in EUDAMED | 47 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 47 |
|---|---|
| Found in the U.S. device database | 36 |
| Share | 76.6 % |
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: United States only. Compumedics Germany GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 054221 0016 | issued | 2028-04-03 |