3C-Medical Intelligence GmbH
DE-MF-000023763 · Germany · Landsberg am Lech
3C-Medical Intelligence GmbH is registered in the European database on medical devices as a manufacturer, with 127 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 118 |
|---|---|
| Class IIb | 9 |
Among these devices, 104 are declared active.
Devices declared under this manufacturer
- BlueBAG BodyFIX 14 Pentagon-Shape 1200x1325mm/52L
- BlueBAG BodyFIX 14 T-Shape 1130x1375 mm/51L
- BlueBAG BodyFIX Rectangular 700x1825mm/50L
- BlueBAG Pentagon Shape 1000x1300 mm/45 L
- BlueBAG Rectangular 650x1500 mm/75 L
- BodyFIX Adhesive Tape (Set of 3)
- BodyFIX Cover Sheet HIP 2000x1400 mm (5 PCS)
- BodyFIX Cover Sheet THORAX 1800x1600 mm (5 PCS)
- BodyFIX Manifold Cushion 700 mm
- Fraxion Linac Table Top Adapter VE (0DoF)
- Fraxion Mouthpiece X-Large P2
- Fraxion Protective Covers (2pcs)
Showing 12 of 127 declared devices.
Catalogue references include P10102-307, P10104-132, P10104-500, P10104-703, P10104-836, P10104-838.
European nomenclature codes declared: V0804, Z11019080, Z11010480, Z11010199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | 3C-Medical Intelligence GmbH (DE) · FDA 9710332 |
| Devices in EUDAMED | 127 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 127 |
|---|---|
| Found in the U.S. device database | 126 |
| Share | 99.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | 3C-MEDICAL INTELLIGENCE GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2017-03-06 |
Licence types: System (1).
Licensed under: HEXAPOD EVO RT COUCHTOP AND IGUIDE SYSTEM.
North American profile: Both markets. 3C-Medical Intelligence GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 049632 0057 | issued | 2029-02-05 |