LiNA Medical AG
CH-MF-000046832 · Switzerland · Root D4
LiNA Medical AG is registered in the European database on medical devices as a manufacturer, with 116 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 33 |
|---|---|
| Class IIa | 83 |
Most frequent device types declared: 5005-E, 5005-E-160, 5005-E-C, 5005-E-C-160; 5010-E, 5010-E-160, 5005-Y, 8150, BL-160; BL-160-E; BL-200; BL-200-E; BL-240; BL-240-E, EB-60, EB-60-BR, EB-100, EB-100-BR, EB-75, EB-125, MOR-1515-1-I, MOR-1515-6-I, MOR2-1515-6-I.
Among these devices, 103 are declared sterile, 34 active.
Authorised representative in the Union: LiNA Medical Polska Sp. z o.o..
Devices declared under this manufacturer
- Drain-Guard
- LiNA Bipolar Loop
- LiNA EndoBag
- LiNA LapGuard
- LiNA MaxFlow EnoHook
- LiNA OperaScope
- LiNA OperaScope Rat Tooth Alligator Grasper
- LiNA OperaScope Recording Module
- LiNA Port
- LiNA PowerBlade
- LiNA SeaStar
- LiNA Skin Hook
Showing 12 of 116 declared devices.
Catalogue references include 1005-06D2-GV, 1005-1, 5005-E-C, BL-200-E, EB-100, MOR-1515-1-I.
European nomenclature codes declared: K01010101, K020199, Z12019099, K01020107, U090399, M04010299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LiNA Medical AG (CH) · FDA 3008693678 |
| Devices in EUDAMED | 116 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 116 |
|---|---|
| Found in the U.S. device database | 24 |
| Share | 20.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LINA MEDICAL APS |
North American profile: Both markets. LiNA Medical AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
TNP/MDR/0050/5851/2026 | cancelled | 2031-02-19 |
HZ 2745863-1 | supplemented | 2031-02-19 |