France Chirurgie Instrumentation SAS
FR-MF-000000463 · France · Paris
France Chirurgie Instrumentation SAS is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|
Among these devices, 6 are declared sterile.
Devices declared under this manufacturer
- Ciliprobe™ – IRIDEX
- OCULAR SHIELD
- PRECIVIA®
- Subcyclo® - Quantel
Catalogue references include S5.200.I, S5.200.P, S6.2301, S6.3060, S9.1701, XLCYCLO.
European nomenclature codes declared: Q02040302, A018002, Q0299, Z12120299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 33.3 % |
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | FRANCE CHIRURGIE INSTRUMENTATION SAS (FCI S.A.S.) |
⚠️ A similar name exists; unverified — why.
What it holds in Canada
| Licences on record | 26 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| Class 3 devices | 18 |
| First licensed | 2000-01-19 |
Licence types: Device Family (13), Single Device (7), Device Group Family (4), System (2).
Licensed under: BIKA(R) BICANALICULAR INTUBATION SETS, MINI MONOKA(R) MONOCANALICULAR INTUBATION SET, MONOKA(R) INTUBATION SETS, PRELOADED PVP PERFORATED PLUG, PUNCTAL PLUG PRELOADED, BIOCERAMIC ORBITAL IMPLANT.