ASSKEA GmbH
DE-MF-000005146 · Germany · Gebesee
ASSKEA GmbH is registered in the European database on medical devices as a manufacturer, with 66 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 66 |
|---|
Most frequent device types declared: Cuff Aspirators, Secretion Aspirators.
Among these devices, 27 are declared active.
Devices declared under this manufacturer
- ASSKEA M30Plus
- ASSKEA S30
- ASSKEA proVisio M28
- ASSKEA procuff M
- Absaugbeutel \
- Allegra M30
- AllegraBag
- Außenbehälter 1000 ml
- Deckel S6 für Mehrweg-Sekretbehälter
- Einweg-Sekretbehälter (250 ml) mit Stufenkonnektor
- Mehrweg-Sekretbehälter (1 l)
- Mehrweg-Sekretbehälter proVisio (1 l)
Showing 12 of 66 declared devices.
Catalogue references include 100001, 100004PLUS-VAN, 100710-3, 100741, 1510214HL33, 458785.
European nomenclature codes declared: A060399, Z12159009, R0580, A0580, A0601010201.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ASSKEA GMBH (DE) · FDA 3013857114 |
| Devices in EUDAMED | 66 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 66 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. ASSKEA GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
111138U2 | issued | 2031-03-08 |