Medicel AG
CH-MF-000016652 · Switzerland · Altenrhein
Medicel AG is registered in the European database on medical devices as a manufacturer, with 318 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 318 |
|---|
Most frequent device types declared: IOL injectors, SMS390S.
Among these devices, 318 are declared sterile, 107 active.
Authorised representative in the Union: Rudolf Riester GmbH.
Devices declared under this manufacturer
- ACCUJECT 2.2-1P Injector Set
- ACCUJECT 3.0-1P Injector Set
- ACCUJECT DUAL 1.6-TL Injector
- ACCUJECT DUAL 2.0-BL Injector
- ACCUJECT SCREW 1.8-BL Injector
- Coaxial I/A 4521P
- Coaxial I/A 6520T\t
- ERGOJECT 1.8-TL Injector
- ERGOJECT 2.4-BL Injector
- Femto I/A Handpieces 30°/20G
- Swiss Coaxial I/A System straight / 20G
- VISCOJECT eco 2.7 Injector Set
Showing 12 of 318 declared devices.
Catalogue references include ADB2000, ADT1600, ERT1800, LP604350C, LP604570, MCS6520T.
European nomenclature codes declared: Q021111, Q021101, Q020699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDICEL AG (CH) · FDA 9681862 |
| Devices in EUDAMED | 318 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 318 |
|---|---|
| Found in the U.S. device database | 53 |
| Share | 16.7 % |
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. Medicel AG is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2073GB448241112 | supplemented | 2027-07-26 |