Sedatelec
FR-MF-000020946 · France · Irigny
Sedatelec is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 3 |
|---|---|
| Class IIa | 38 |
Among these devices, 25 are declared sterile, 3 implantable, 15 active.
Devices declared under this manufacturer
- AGISTIM DUO
- APEX 96
- APEX Gold 96
- ASP Multi CLASSIC 320
- ASP Original CLASSIC 64
- ASP Original CLASSIC 8
- ASP Original GOLD 64
- ASP Original TITANIUM 200
- ASP PERMA REGULAR 8
- FOREVER NEEDLE REGULAR (1x80)
- PREMIO 32 EVO laser A-G program
- PREMIO 32D EVO laser
Showing 12 of 41 declared devices.
Catalogue references include 108268, 110488, 110616, 111181, 112802, 113201.
European nomenclature codes declared: A019002, Z120615, Z120623, Z120622, V9099, Z129005.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SEDATELEC (FR) · FDA 8020802 |
| Devices in EUDAMED | 41 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 41 |
|---|---|
| Found in the U.S. device database | 21 |
| Share | 51.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SEDATELEC |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| Class 3 devices | 3 |
| First licensed | 1999-05-27 |
Licence types: Single Device (3), Device Family (3), System (1).
Licensed under: PREMIO 20 DT, AGISTIM DUO, ASP AIGUILLE D'ACUPUNCTURE SEMI-PERMANENTE, LONG TERM ACUPUNCTURE NEEDLE, PREMIO 10 MOXA (LAMPE INFRAROUGE), PREMIO 32 LASERS.
North American profile: Both markets. Sedatelec is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 015735 0033 | supplemented | 2030-06-03 |