OrangeCAD Med GmbH
DE-MF-000023347 · Germany · Karlsruhe
OrangeCAD Med GmbH is registered in the European database on medical devices as a manufacturer, with 123 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 123 |
|---|
Most frequent device types declared: Abformpfosten, Driver for Handpiece, Driver for Ratchet, Scanbody, Verschlusskappe Multi-Unit.
Catalogue references include 31.031.71.031H, 31.063.71.025H, ATEV2301H, ATTX2303H, CLSR2306H, NBAV2304H.
European nomenclature codes declared: Q010207, Z12119099, P01020180, Z12110180.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ORANGECAD MED GMBH (DE) · FDA 3030488649 |
| Devices in EUDAMED | 123 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 123 |
|---|---|
| Found in the U.S. device database | 70 |
| Share | 56.9 % |
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. OrangeCAD Med GmbH is registered in the United States but was not found in the Canadian register.