Cercare Medical A/S
DK-MF-000002148 · Denmark · Århus
Cercare Medical A/S is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 14 |
|---|---|
| Class IIb | 12 |
Among these devices, 26 are declared active.
Devices declared under this manufacturer
- Capillary Function
- Cercare Medical Neurosuite
- ICH Bleeding Detection
- LVO Occlusion Detection
- Oncology Virtual Expert
- Virtual Expert
Showing 12 of 26 declared devices.
Catalogue references include Cercare Medical Neurosuite ver. 15, Cercare Medical Neurosuite ver.18, ICH Bleeding Detection ver. 15, ICH Bleeding Detection ver. 18, LVO Occlusion Detection ver. 15, LVO Occlusion Detection ver. 18.
European nomenclature codes declared: Z110603, Z11030592.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CERCARE MEDICAL A/S (DK) · FDA 3019844085 |
| Devices in EUDAMED | 26 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 26 |
|---|---|
| Found in the U.S. device database | 17 |
| Share | 65.4 % |
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. Cercare Medical A/S is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 102958 0008 | issued | 2027-09-27 |