Manfred Sauer GmbH
DE-MF-000006287 · Germany · Lobbach
Manfred Sauer GmbH is registered in the European database on medical devices as a manufacturer, with 621 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 621 |
|---|
Among these devices, 233 are declared sterile.
Devices declared under this manufacturer
- Gel-Einmalkatheter IQ-Cath, für den ISK, nicht gebrauchsfertig, ohne
- Hydrophiler Einmalkatheter IQ-Cath - Frauen, für den ISK, sofort gebr
- Hydrophiler Einmalkatheter IQ-Cath, für den ISK, sofort gebrauchsfert
- KIC-Kondome - Extradünn, mit gestanzter Lochung, 2 Latex-Kondome, Ø 3
- KIC-Kondome - Original, mit gestanzter Lochung, 30 Latex-Kondome, Ø 2
- Latex-Kondome mit Schlauchansatz - DD, aus Naturkautschuk, Ø 35 mm, K
- SAUER-Funktionsbeutel, 2,0 l, Schiebehahn, gestufter Adapter, fest mo
- SAUER-Funktionsbeutel, 2,0 l, Schwenkhahn, glatter Adapter, fest mont
- SAUER-NephSys-Beutel, 0,5 l, Drehhahn, Luer-Anschluss, fest montiert,
- SAUER-Rollibeutel, 1,3 l, Schiebehahn, gestufter Adapter, fest montie
- SAUER-Rollibeutel, 1,3 l, Schwenkhahn, gestufter Adapter, fest montie
- Selbstklebende Kondome, SAUER-Comfort - Rot, Schlauchansatz, stärkere
Showing 12 of 621 declared devices.
Catalogue references include 103.30.D-2, 701.1222-30, 720.9999.S, 771.11120-10, 97.6001.24, IQ2302.14.
European nomenclature codes declared: A06030301, U070201, U010199, U0780, A0680.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 621 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 621 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MANFRED SAUER GMBH |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2012-01-31 |
Licence types: Device Family (2).
Licensed under: IQ CATH-TYPE H (HYDROPHILIC SINGLE USE CATHETE, IQ CATH - TYPE G (SINGLE USE CATHETERS FOR USE.
North American profile: Canada only. Manfred Sauer GmbH holds a Canadian licence but was not found in the U.S. register.