A.M.I. Agency for Medical Innovations GmbH
AT-MF-000016792 · Austria · Feldkirch
A.M.I. Agency for Medical Innovations GmbH is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 23 |
|---|
Among these devices, 8 are declared sterile, 10 reusable, 2 active.
Devices declared under this manufacturer
- A.M.I. HAL Needleholder
- ATOMS Tunneller
- Comfort Drain Grasper
- FiXcision
- More-Cell Bag
- More-Cell-Safe
- More-Cell-Safe 30
- RAR Flexi Probe
- Wi-3 HAL-RAR Unit
- disposable Knotpusher
- i-Cut
- i-Stitch
Showing 12 of 23 declared devices.
Catalogue references include ATS5010, CDS2010, FIX2001, IST1040, K6601, MCS5111.
European nomenclature codes declared: G020401, U0780, K01020107, Z12011301, A018002, Z12080299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH (AT) · FDA 3005049530 |
| Devices in EUDAMED | 23 |
| Country of registration | Austria |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| Class 3 devices | 3 |
| First licensed | 2010-08-17 |
Licence types: System (3), Device Family (2), Device Group Family (1), Single Device (1).
Licensed under: TUNNELLERS, A.M.I. INCONTINENCE SLING, A.M.I. RAR FLEXI PROBE, ATOMS, MORE-CELL-SAFE, FIXCISION.
North American profile: Both markets. A.M.I. Agency for Medical Innovations GmbH is registered in both the United States and Canada.