Cetro Medical AB
SE-MF-000012172 · Sweden · Smålandsstenar
Cetro Medical AB is registered in the European database on medical devices as a manufacturer, with 96 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 96 |
|---|
Most frequent device types declared: 1200, 120S, 1300, 1500, 15A0.
Among these devices, 14 are declared sterile.
Devices declared under this manufacturer
- CETRO® Bellow Reusable
- CETRO® Proctoscope Large
- CETRO® Proctoscope Small
- CETRO® Tube Proctoscope
- Connector I 7x10 mm
- EasySpec® Large
- EasySpec® XL
- EasySpec® XS Sterile
- Easyspec® Large SOLO
- Lid UNO™
- Proctoscope Select™
- VagiPress® Solid 1x
Showing 12 of 96 declared devices.
Catalogue references include 1251-100, 1321, 1422-1, 1524, 1541, 1641.
European nomenclature codes declared: U089006, A070199, G02060302, G02060399, Z1208010485, U089002.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CETRO MEDICAL AB (SE) · FDA 3006695553 |
| Devices in EUDAMED | 96 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 96 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. Cetro Medical AB is registered in the United States but was not found in the Canadian register.