APrevent Biotech GmbH
Austria AT-MF-000001435 Last updated 21 Oct 2026
- Devices
- 25
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Vois-L Ref APV004
Vois-Xs Ref APV001
Vois-S Ref APV002
Vois-S_3.0 Ref APV009
Vois-M Ref APV003
Vois-M_3.5 Ref APV010
Vois-XS_3.0 Ref APV008
Vois-L_3.5 Ref APV011
APrevent® VOIS Instrument Ref APT108
APrevent® VOIS Instrument Ref APT115
APrevent® VOIS Instrument Ref APT109
APrevent® VOIS Instrument Ref APT102
APrevent® VOIS Instrument Ref APT103
APrevent® VOIS Instrument Ref APT101
APrevent® VOIS Instrument Ref APT105
APrevent® VOIS Instrument Ref APT107
APrevent® VOIS Instrument Ref APT112
APrevent® VOIS Instrument Ref APT113
APrevent® VOIS Instrument Ref APT106
APrevent® VOIS Instrument Ref APT110
APrevent® VOIS Instrument Ref APT100
APrevent® VOIS Instrument Ref APT111
APrevent® VOIS Instrument Ref APT114
APrevent® VOIS Instrument Ref APT116
APrevent® VOIS Instrument Ref APT104
EUDAMED certificates
Notified body 0297 2 certificates
- 1000305807 Issued
Technical documentation EU MDR
- Issued
- 30 Mar 2026
- Expires
- 29 Mar 2031
- 1000305808 Supplemented
Quality management system EU MDR
- Issued
- 30 Mar 2026
- Expires
- 26 Mar 2030
- Reason
- Add device or group
Related companies
Notified bodies
- Notified body 0297
About
APrevent proudly announces that its flagship product, VOIS Implant, has been honored with the 2024 Biotechnology and Medical Care Quality Award - Silver Award. This prestigious recognition highlights the company’s commitment to advancing patient care through groundbreaking medical technologies.
What APrevent Biotech GmbH makes
APrevent Biotech GmbH manufactures the APrevent® VOIS Instrument, a device designed for specific medical applications within its product line. The instrument appears to be a single, standardized product used in clinical settings, though its exact procedural use is not specified beyond the device name.
The APrevent® VOIS Instrument is classified as a Class I medical device and is registered in the EU’s eudamed database. The company is based in Austria and adheres to EU regulatory requirements for Class I devices.
Frequently asked questions
What types of medical devices does APrevent Biotech GmbH manufacture?
APrevent Biotech GmbH manufactures the APrevent® VOIS Instrument, which is a single, standardized medical device. Based on the available information, this instrument is designed for specific clinical applications, though the exact procedural use is not detailed beyond the device name. The company specializes in this one product line, which is classified as a Class I medical device.
Where is APrevent Biotech GmbH based?
APrevent Biotech GmbH is based in Austria. The company operates within the European Union, which means its devices must comply with EU regulatory standards, including registration in relevant databases like eudamed.
Which regulatory registries list APrevent Biotech GmbH’s devices?
APrevent Biotech GmbH’s devices are listed in the EU’s eudamed database. This registry is used to track medical devices that are legally placed on the market within the European Economic Area, ensuring transparency and compliance with EU regulations.
How are APrevent Biotech GmbH’s devices classified under EU regulations?
APrevent Biotech GmbH’s devices, specifically the APrevent® VOIS Instrument, are classified as Class I medical devices. This classification is determined by the risk associated with the device’s use and its intended purpose. Class I devices are generally considered low-risk and typically require less stringent regulatory oversight compared to higher-risk classes.
Information
- Country
- Austria
- Address
- 13, Wiedner Gürtel, Vienna, Austria
- Website
- www.apreventmed.com/en/
- linkedin.com/company/aprevent
- [email protected]
- PRRC contact
- Guan-Min Ho
- EUDAMED SRN
- AT-MF-000001435