EU Manufacturer
🇦🇹 Austria
Active
GENSPEED Biotech
SRN: AT-MF-000013008
·
Gewerbepark 2, 4261 Rainbach, Austria
Basic UDI-DIs
1
Total Devices
1
On Market
1
Off Market
0
Certificates
4
Valid
2
Expiring < 6mo
0
Countries
1
Watch GENSPEED Biotech for changes
We'll email you when it registers new devices, or a certificate is issued or withdrawn.
Basic Information
- Address
- Gewerbepark 2, 4261 Rainbach, Austria
- [email protected]
- Phone
- +43 7942 20910
- Website
- www.genspeed-biotech.com
Regulatory Overview
Regulation
Loading...
Eu Ivdr
1
Classification
Loading...
Eu Ivd Class B
1
Device Types
Loading...
Certificate Health
Total
4
Valid
2
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDR Technical Documentation | ITDA/00002/0 v002 | QMD Services GmbH | IVDR | Sep 2024 | Sep 04, 2029 | Issued |
| IVDR Technical Documentation | ITDA/00002/0 v001 | QMD Services GmbH | IVDR | Sep 2024 | Sep 04, 2029 | Withdrawn |
| IVDR QMS | IQMS/00002/0v001 | QMD Services GmbH | IVDR | Sep 2024 | Sep 04, 2029 | Issued |
| IVDR Technical Documentation | ITDA/00002/0 | QMD Services GmbH | — |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇦🇹 Austria
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Vitamin D xPOC | EU IVDR | Eu Ivd Class B | On Market | 1 |