Starmed
DE-MF-000026331 · Germany · Stetten am Bodensee
Starmed is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 12 |
|---|
Most frequent device types declared: ECMO-CARRIER for Lifemotion® ECMO unit, Heavystar, ITS Terra 100.
Among these devices, 10 are declared active.
Devices declared under this manufacturer
- Heavystar
- ITS Terra 100
- Starmed ECMO-CARRIER P1 for Lifemotion® ECMO unit
- Starmed ECMO-CARRIER P2 for Lifemotion® ECMO unit
Catalogue references include 02-010-0001, 02-010-0002, 02-010-0007, 02-010-0009, 02-010-0010, 02-017-0001.
European nomenclature codes declared: Z12019010, C030180.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | STARMED CO.,LTD (KR) · FDA 3013557681 |
| Devices in EUDAMED | 12 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | STARMED CO., LTD. |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| Class 3 devices | 1 |
| First licensed | 2023-02-28 |
Licence types: Device Group (5), Device Family (2), Single Device (1).
Licensed under: VIVA COMBO RF GENERATOR, STAR RF ELECTRODE (UNI-FACED AND FIXED), STAR BIPOLAR RF ELECTRODE, ELRA ELECTRODE, VIVA RF ELECTRODE, OCTOPUS RF ELECTRODE.
North American profile: Both markets. Starmed is registered in both the United States and Canada.