Contract Medical International GmbH
DE-MF-000007409 · Germany · Dresden
Contract Medical International GmbH is registered in the European database on medical devices as a manufacturer, with 185 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 129 |
|---|---|
| Class IIb | 10 |
| Class IIa | 46 |
Most frequent device types declared: FG-02234-002A, FG-02234-004A, FG-02234-005A, FG-02234-008A, FG-04552-002.
Among these devices, 185 are declared sterile, 10 implantable.
Devices declared under this manufacturer
- DuraSheath Introducer Sheath System
- Fortress Introducer Sheath System
- Fortress®
- blueflow Venous Stent
Showing 12 of 185 declared devices.
Catalogue references include 386591, 386592, 386594, FG-04015, FG-05060, FG-05060-F-HS.
European nomenclature codes declared: C0502, C0599, P0704020299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Contract Medical International GmbH (DE) · FDA 3003637635 |
| Devices in EUDAMED | 185 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 185 |
|---|---|
| Found in the U.S. device database | 77 |
| Share | 41.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CONTRACT MEDICAL INTERNATIONAL, GMBH |
North American profile: Both markets. Contract Medical International GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2254506TD01 | supplemented | 2027-06-01 |
2254506CE03 | issued | 2027-06-01 |
2254506CE02 | issued | 2027-06-01 |
2254506CE01 | issued | 2027-06-01 |