Lentismed d.o.o.
HR-MF-000018298 · Croatia · Zagreb
Lentismed d.o.o. is registered in the European database on medical devices as a manufacturer, with 290 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 290 |
|---|
Among these devices, 90 are declared sterile.
Devices declared under this manufacturer
- LENTELL Convex II L / pre-cut 28mm
- LENTELL Convex II L / pre-cut 32mm
- LENTELL IleoBag II XL; transparent
- LENTELL IleoBag II XXS; transparent
- LENTELL OstoZip II
- LENTELL OstoZip II M; transparent
- LENTELL OstoZip II; small
- LENTELL flexi II S
- LENTELL urobag II; transparent
- LentisCath Nelaton, Female, 16 Fr/Ch, 20cm
- LentisCath Tiemann, Male, 10 Fr/Ch, 40cm
- LentisCath+ Nelaton, Pediatric, 6 Fr/Ch, 40cm
Showing 12 of 290 declared devices.
Catalogue references include 101310, 101314, 101420, 201115-1, 201119, 201126.
European nomenclature codes declared: U01010501, U01010601, A1002010401, A1001020102, A1001020101, A10020302.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 290 |
| Country of registration | Croatia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 290 |
|---|---|
| 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: Neither register. Lentismed d.o.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
M.2022.MDR.1008 | issued | 2027-12-11 |