Corcym S.r.l.
IT-MF-000027865 · Italy · Milan
Corcym S.r.l. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|---|
| Class I | 2 |
Most frequent device types declared: Bicarbon Fitline Aortic and Mitral Rotators Set; Bicarbon Overline Aor, Dual Collapser Base, PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE, PERCEVAL S SUTURELESS HEART VALVE, Trays.
Among these devices, 2 are declared sterile, 2 implantable, 6 reusable.
Devices declared under this manufacturer
- Accessory Tray
- Bicarbon Fitline Aortic and Mitral Rotators Set
- Memo 3D Accessory tray
- Memo 4D Accessory tray
- PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
- PERCEVAL S SUTURELESS HEART VALVE
- Perceval Dual Collapser Base
Catalogue references include ICV0732, ICV1230, ICV1232, ICV1343, ICV1358, PVF-S.
European nomenclature codes declared: L070799, P070301010201, P07038003.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Corcym S.r.l. (IT) · FDA 3005687633 |
| Devices in EUDAMED | 8 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 7 |
| Share | 87.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CORCYM S.R.L. |
What it holds in Canada
| Licences on record | 22 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 14 |
| Class 4 devices | 8 |
| First licensed | 1998-12-30 |
Licence types: Device Group Family (6), Device Family (5), Single Device (5), Device Group (5).
Licensed under: CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTH, CARBOMEDICS ANNULOFLEX ANNULOPLASTY SYSTEM, CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORT, CARBOMEDICS OPTIFORM, ORBIS HEART VALVE, CARBOMEDICS PROSTHETIC HEART VALVE.
North American profile: Both markets. Corcym S.r.l. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G12 001664 0050 | issued | 2028-04-03 |
G15 001664 0070 | issued | 2030-11-02 |