implantcast GmbH
DE-MF-000010002 · Germany · Buxtehude
implantcast GmbH is registered in the European database on medical devices as a manufacturer, with 3 249 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 3 247 |
|---|---|
| Class I | 1 |
| Class IIb | 1 |
Most frequent device types declared: EB12TCCINST, FJ12JCINST, KNB12FBTTSINST, KNB12MTFMINST, KNB12TTCONINST.
Among these devices, 3 are declared sterile, 2 implantable, 1 234 reusable, 5 with a measuring function.
Devices declared under this manufacturer
- 5C®
- 5C® CR
- 5C® MEDic
- ACS®
- ACS® FB
- ACS® MB
- ACS® PS
- ACS® SC
- ACS® UNI
- AGILON® MI
- CarpoFit®
- ICARA®
Showing 12 of 3 249 declared devices.
Catalogue references include 00510905, 00710011, 42102316, 42155053, 42160712, 42200346.
European nomenclature codes declared: L091199, L0922, L091201, L030199, L0317, L091102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | implantcast GmbH (DE) · FDA 3012523063 |
| Devices in EUDAMED | 3 249 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 3 249 |
|---|---|
| Found in the U.S. device database | 690 |
| Share | 21.2 % |
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. implantcast GmbH is registered in the United States but was not found in the Canadian register.