Novanta Medical GmbH
DE-MF-000005815 · Germany · Berlin
Novanta Medical GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 |
|---|
Most frequent device types declared: FZ122, FZ123, ST254.
Among these devices, 1 are declared sterile.
Devices declared under this manufacturer
- Hose for C02 gas bottle ISO:US 1.5m / 4.92 ft
- Hose for CO2 central gas supply DIN:US, 3 m / 9.8 ft
- Hose for CO2 gas bottle DIN:US 1.5m / 4.92 ft
- Hose for CO2 gas bottle Pin:US, 1.5 m / 4.92 ft
Catalogue references include 0620050900, 0620050901, 0620050904, PG122SU, Z0499-01.
European nomenclature codes declared: Z12029099, Z12029085.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Novanta Medical GmbH (DE) · FDA 3001556604 |
| Devices in EUDAMED | 5 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 4 |
| Share | 80.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NOVANTA MEDICAL GMBH |
What it holds in Canada
| Licences on record | 10 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 10 |
| First licensed | 2010-09-10 |
Licence types: System (9), Device Group Family (1).
Licensed under: TUBING SETS, FLUID MANAGEMENT SYSTEM H202/M202, INSUFFLATOR 50L FM134, PUMP PM304, PNEUMOCLEAR, GOFLO PUMP.
North American profile: Both markets. Novanta Medical GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1015743-1 | amended | 2030-02-04 |