Drägerwerk AG & Co. KGaA
DE-MF-000005329 · Germany · Lübeck
Drägerwerk AG & Co. KGaA is registered in the European database on medical devices as a manufacturer, with 1 247 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 196 |
|---|---|
| Class IIa | 1 051 |
Most frequent device types declared: 041382, 1080366K19Z000, 1080556K19Z000, 11030276K19Z00, 2080246K19Z000.
Among these devices, 2 are declared sterile, 279 active, 72 with a measuring function.
Devices declared under this manufacturer
- AIR ZV-Schl 3.0m NIST EN DIN
- Adapter gerade 18/11 (A)
- Anesthesia Set Coax GSL 230
- Atemschlauch 22/22 (A) 25
- Babytherm 8004
- ECG Neo ESU TRUNK 3-LEADS 2.5M
- Einweg-Temp.sonde Erw 1.6m
- Einweghandgriff Polaris, Solo
- Konnektor 22mmID/22mmID
- Liftarm -Fra.Rail-Slide+KB+300
- Softbed TN300
- VAC ZV-Schl 3.0m NIST EN DIN
Showing 12 of 1 247 declared devices.
Catalogue references include 2M22370, GG10481, M35499, MP00358, MP00991, MP01942.
European nomenclature codes declared: Z120309, Z1203019080, R02010101, A060399, R0301010202, V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 1 247 |
| 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 | 1 247 |
|---|---|
| Found in the U.S. device database | 515 |
| Share | 41.3 % |
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: Neither register. Drägerwerk AG & Co. KGaA was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 010578 0039 | supplemented | 2030-03-17 |