ComfTech
IT-MF-000028032 · Italy · Monza
ComfTech is registered in the European database on medical devices as a manufacturer, with 54 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 52 |
|---|---|
| Class IIb | 2 |
Among these devices, 2 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- BABY SENSORIZED PRINTED BELT - PRONE MODEL SIZE 0
- BABY SENSORIZED TEXTILE BELT - PRONE MODEL SIZE 2
- BABY SENSORIZED TEXTILE BELT - SUPINE MODEL SIZE 1
- BABY SENSORIZED TEXTILE BELT - SUPINE MODEL SIZE 2
- SENIOR SENSORIZED PRINTED BELT SIZE M
- SENIOR SENSORIZED PRINTED BELT SIZE XXS
- SENIOR SENSORIZED TEXTILE UNIT SIZE XXS
- WASHABLE SENSORIZED TEXTILE BELT - PRONE MODEL SIZE 1
- WASHABLE SENSORIZED TEXTILE BELT - PRONE MODEL SIZE M/L
- WASHABLE SENSORIZED TEXTILE BELT - SUPINE MODEL SIZE 2
- WASHABLE SENSORIZED TEXTILE BELT - SUPINE MODEL SIZE XXS
- WOMEN SENSORIZED TEXTILE UNIT SIZE M
Showing 12 of 54 declared devices.
Catalogue references include CMF9TXM11, CMF9TXM13, CMF9TXM14, CMF9TXM15, CMF9TXM16, CMF9TXM17.
European nomenclature codes declared: Z12030280, Z12039099, Z12020380.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 54 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 54 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. ComfTech was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1342906 1 | issued | 2029-11-25 |