Mectalent Oy
FI-MF-000012330 · Finland · Oulu
Mectalent Oy is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 11 |
|---|---|
| Class IIa | 3 |
Most frequent device types declared: JR-001, JR-003, JR-007, JR-009, JR-010.
Among these devices, 11 are declared implantable, 2 reusable.
Devices declared under this manufacturer
- CC-Clip Curved Lasso Guide
- CC-Clip Lasso Guide
- JR-001 CC-Clip 14mm
- JR-002 CC-Clip 16mm
- JR-003 CC-Clip 20mm
- JR-007 SC-Clip, round 10mm
- JR-008 SC-Clip, round 12mm
- JR-009 SC-Clip, rectangle, small
- JR-010 SC-Clip, rectangle, large
- JR-011 SC-Clip, round 10mm, curved
- JR-012 SC-Clip, round 12mm, curved
- JR-013 SC-Clip, rectangle, small, curved
Showing 12 of 14 declared devices.
Catalogue references include JR-001, JR-003, JR-009, JR-010, JR-011, JR-012.
European nomenclature codes declared: H02010299, L0922, P091399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MECTALENT LTD. (FI) · FDA 3013156185 |
| Devices in EUDAMED | 14 |
| Country of registration | Finland |
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. Mectalent Oy is registered in the United States but was not found in the Canadian register.