Medela AG
CH-MF-000018913 · Switzerland · Baar
Medela AG is registered in the European database on medical devices as a manufacturer, with 226 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 223 |
|---|---|
| Class IIb | 3 |
Among these devices, 29 are declared sterile, 32 active, 3 with a measuring function.
Authorised representative in the Union: Medela Medizintechnik GmbH & Co. Handels KG.
Catalogue references include 008.0229, 071.0003, 077.0169, 077.0564, 077.0731, 101035264.
European nomenclature codes declared: Z12080399, A060399, Z120105, A060102, A0680, U1003.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDELA AG (CH) · FDA 3002807523 |
| Devices in EUDAMED | 226 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 226 |
|---|---|
| Found in the U.S. device database | 124 |
| Share | 54.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDELA LLC |
What it holds in Canada
| Licences on record | 13 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 13 |
| First licensed | 2017-10-06 |
Licence types: System (5), Device Group Family (5), Single Device (2), Device Group (1).
Licensed under: SONATA BREAST PUMP, SYMPHONY PUMPING KITS, PUMP IN STYLE, SYMPHONY BREAST MILK INITIATION KIT-NON STERIL, POWERED BREAST PUMPS, HANDS-FREE COLLECTION CUPS.
North American profile: Both markets. Medela AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 011634 0235 | issued | 2027-01-16 |