QUESTALPHA GmbH & Co. KG
DE-MF-000005033 · Germany · Eschenburg
QUESTALPHA GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 35 |
|---|
Most frequent device types declared: 30601.
Among these devices, 20 are declared sterile.
Devices declared under this manufacturer
- Sugi Eyedrain, 155 x 4 x 1 mm, sterile, 20 x 1 pc.
- Sugi Eyespear (blunt tip), rectangular white handle, sterile, 20 x 10
- Sugi Eyespear (pointed tip), 17 x 7 mm, non-sterile, 50 x 10pcs.
- Sugi Eyespear (pointed tip), rectangular white handle, non-sterile, 20
- Sugi Eyespear (pointed tip), rectangular white handle, sterile, 20 x 1
- Sugi Eyespear, Cellulose, round blue handle, 17 x 8 mm, non-sterile, 5
- Sugi Rhino Swabs, sterile, 12 x 10 mm, 10 x 6 pcs.
- Sugi Rhino-Long, 40 x 12 mm, sterile, 10 x 4 pcs.
- Sugi Sponge Points, triangular, 17 x 8 mm, non-sterile, 500 pcs.
- Sugi Sponge Points, triangular, 17 x 8 mm, sterile, 20 x 10 pcs.
- Sugi Sponge Strips, rectangular, 35 x 7,5 mm, non-sterile, 500 pcs.
- Sugi Sponge Strips, rectangular, 35 x 7,5 mm, sterile, 20 x 10 pcs.
Showing 12 of 35 declared devices.
Catalogue references include 30601, 30613, 30622, 30675, 30761, 30901.
European nomenclature codes declared: M040299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | QUESTALPHA GmbH & Co. KG (DE) · FDA 3017475063 |
| Devices in EUDAMED | 35 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 35 |
|---|---|
| Found in the U.S. device database | 20 |
| Share | 57.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | QUESTALPHA GMBH & CO. KG |
North American profile: Both markets. QUESTALPHA GmbH & Co. KG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G26 110417 0005 | reissued | 2031-10-17 |
G15 110417 0006 | reissued | 2031-10-17 |