GENSPEED Biotech
AT-MF-000013008 · Austria · Rainbach
GENSPEED Biotech is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- FSME IgG xPOC
- GENSPEED R2 Analyzer
- Perio POC Pro Cartridge
- PerioPOC Pro
- Vitamin D xPOC
- xPOC Cartridge
Catalogue references include GSHW001, GSPC2, GSPC3, IATK215, IATK216, PPTK002.
European nomenclature codes declared: W01021699, W0105011699, W0201069099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| Country of registration | Austria |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. GENSPEED Biotech was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITDA/00002/0v003 | issued | 2029-09-04 |
IQMS/00002/0v001 | issued | 2029-09-04 |