Redax S.p.A.
IT-MF-000019320 · Italy · Poggio Rusco
Redax S.p.A. is registered in the European database on medical devices as a manufacturer, with 235 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 235 |
|---|
Most frequent device types declared: 10800, Alivia Drenaggio percutaneo 7 CH, CATETERE TORACICO SILICONE CH 12, DRENAGGIO TIPO T-KEHR CH 9, Drenaggio soffietto 500 ml c/sacca 600 ml.
Among these devices, 235 are declared sterile.
Devices declared under this manufacturer
- Catetere toracico retto CH 30
- Catetere toracico retto CH 33
- Circuito chiuso 500 ml e drenaggio tondo CH 10
- Circuito chiuso 500 ml e drenaggio tondo CH 15
- DRENTECH PUMP 100 ML SET SERBATOIO E DRENAGGIO PIATTO C/AGO 3X7 MM
- DRENTECH PUMP 200 ML SET SERBATOIO E DRENAGGIO PIATTO C/AGO 3X7 mm
- Drenaggio piatto tipo Jackson Pratt con ago 4x13 mm
- Drenaggio scanalato piatto 4 x 10 mm
- Drenaggio tondo tipo Jackson Pratt CH 7
- Drentech Bag circuito chiuso tipo Robinson CH 12
- Drentech Bag circuito chiuso tipo Robinson CH 30
- SMART DRAIN SCANALATO CH 32
Showing 12 of 235 declared devices.
Catalogue references include 10466, 10819, 21412, 21430, 21610, 21615.
European nomenclature codes declared: A0601010402, A0601010403, A060204, A070199, A0601010401, A0601010499.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | REDAX S.P.A (IT) · FDA 3013058659 |
| Devices in EUDAMED | 235 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 235 |
|---|---|
| Found in the U.S. device database | 98 |
| Share | 41.7 % |
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: United States only. Redax S.p.A. is registered in the United States but was not found in the Canadian register.