Ulrich GmbH & Co. KG
DE-MF-000006411 · Germany · Ulm
Ulrich GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 340 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 158 |
|---|---|
| Class IIa | 176 |
| Class I | 6 |
Most frequent device types declared: Carrier, Easy-Click-Cassette incl. Spikes for flex cassette, Layer, Patient hose, Rod, sterile.
Among these devices, 188 are declared sterile, 164 implantable, 1 active.
Devices declared under this manufacturer
- ADD
- ADDplus
- Contrast Booster
- neon³
- pezo
- tezo
- uCentum
- ulrich medical disposables
Showing 12 of 340 declared devices.
Catalogue references include CS 3890-017-003, CS 3890-019-002, CS 3890-020-002, CS 3904-40-32-S, CS 3904-40-34-S, CS 7040-3.
European nomenclature codes declared: P09070301, V0402, A03010105, P09070101, Z11030580, P091399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ULRICH GMBH & CO. KG (DE) · FDA 9612420 |
| Devices in EUDAMED | 340 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 340 |
|---|---|
| Found in the U.S. device database | 48 |
| Share | 14.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ULRICH GMBH & CO. KG |
What it holds in Canada
| Licences on record | 14 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| Class 3 devices | 9 |
| First licensed | 2006-02-21 |
Licence types: System (10), Device Family (3), Device Group (1).
Licensed under: ANTERIOR DISTRACTION DEVICE (ADD), OBELISC SYSTEM (VERTEBRAL BODY REPLACEMENT), ADDPLUS (ANTERIOR DISTRACTION DEVICE PLUS), OSMIUM SCREWS AND CANCELLOUS BONE SCREWS, TITA, COSMICMIA (DYNAMIC MINIMALLY INVASIVE SYSTEM), INSTRUMENT TRAYS.
North American profile: Both markets. Ulrich GmbH & Co. KG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
20490GB450260605 | supplemented | 2031-03-23 |
20379GB448240528 | supplemented | 2028-04-20 |