KOELIS
FR-MF-000000830 · France · MEYLAN
KOELIS is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 31 |
|---|
Most frequent device types declared: 3D Side-Fire Endocavity compact probe, Con Lead and Lin Lead guides, Nail, PROMAP LITE, Reusable PERINE guides.
Among these devices, 1 are declared sterile, 8 active, 7 with a measuring function.
Devices declared under this manufacturer
- 2D Abdominal probe
- Con Lead
- NAIL 18G
- Perine Full Grid 14G
- Perine Full Grid 18G
- Perine Grid 18G
- Perine Nail
- Side-Fire Endocavitary 3D ultrasound probes
- Steady Pro Arm System
- Steady Pro Universal clamping base
- Steady Pro for Full-3D endocavity side-fire probe
- Steady Pro support for Full-3D endocavity end-fire probe
Showing 12 of 31 declared devices.
Catalogue references include K3DEL00, KPHA.00, KPHA.01.EL, KRNG.AB.1x, KRNG.EL2.1x, KRNG.EL4.14.
European nomenclature codes declared: Z11049080, Z1104020202, Z11040104, Z110402010201, Z11040185, Z110402010101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | KOELIS (FR) · FDA 3008487708 |
| Devices in EUDAMED | 31 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| Found in the U.S. device database | 26 |
| Share | 83.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | KOELIS |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| Class 3 devices | 1 |
| First licensed | 2014-06-13 |
Licence types: Single Device (2), Device Family (1), System (1).
Licensed under: GUIDE REUTILISABLE KOELIS, TRINITY, STERILE DISPOSABLE GUIDE, PROMAP LITE.
North American profile: Both markets. KOELIS is registered in both the United States and Canada.