Baitella AG
CH-MF-000017307 · Switzerland · Zürich
Baitella AG is registered in the European database on medical devices as a manufacturer, with 72 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 72 |
|---|
Most frequent device types declared: 2628.xx 3628.xx, 3640.xx 3511.xx, 3590.xx 3670.xx, 3690.xx, 3828.xx, 3840.xx, 3855.xx 4840.xx, 4850.xx 5850.xx, 5870.xx 5.75x, 4646.xx, 4670.xx 6632.xx, 6646.xx, 6656.xx, 6740.xx, 5.87x.
Authorised representative in the Union: Baitella GmbH.
Devices declared under this manufacturer
- FISSO ARM SUPPORT LATERAL
- FISSO Anaesthetic Tube Holder
- FISSO Arm Support Lateral
- FISSO Arm Support Vertical
- FISSO Body Support
- FISSO Endoscope Holder
- FISSO Instrument Holder
- FISSO Instrument Holder Double Arm
- FISSO Lateral Pad Circular
- FISSO Quick Release Instrument (QR)
- FISSO Rails Clamp
- FISSO Rails Clamp Insulated
Showing 12 of 72 declared devices.
Catalogue references include 3690.46-10053, 3840.48-4524, 5.255-VE, 5.716, 5.872-VE, 6646.01.
European nomenclature codes declared: V0880.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BAITELLA AG (CH) · FDA 3001415205 |
| Devices in EUDAMED | 72 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 72 |
|---|---|
| Found in the U.S. device database | 49 |
| Share | 68.1 % |
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. Baitella AG is registered in the United States but was not found in the Canadian register.