Acandis GmbH
DE-MF-000006259 · Germany · Pforzheim
Acandis GmbH is registered in the European database on medical devices as a manufacturer, with 102 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 102 |
|---|
Among these devices, 102 are declared sterile, 102 implantable.
Devices declared under this manufacturer
- ACCERO Stent
- ACCLINO flex plus Stent
- CARESTO heal Carotid Stent Set
- CARESTO heal Carotid Stent Set - Tapered
Showing 12 of 102 declared devices.
Catalogue references include 01-000881, 01-001124, 01-001155, 01-001183, 01-001199, 01-001201.
European nomenclature codes declared: P0799.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 102 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 102 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ACANDIS GMBH |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 4 devices | 5 |
| First licensed | 2025-06-12 |
Licence types: Device Family (4), Device Group Family (2).
Licensed under: CREDO STENT, NEUROSPEED PTA BALLOON CATHETER, NEUROSLIDER DLC MICROCATHETER, DERIVO 2HEAL EMBOLISATION DEVICE, CREDO HEAL STENT, ACCLINO HEAL STENT.
North American profile: Canada only. Acandis GmbH holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000331813 | supplemented | 2030-01-30 |
1000331236 | supplemented | 2028-03-22 |
1000308141 | supplemented | 2030-08-06 |
1000308139 | supplemented | 2029-09-18 |