Molecular Health GmbH
Germany Last updated 21 Oct 2026
- Devices
- 3
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
EUDAMED certificates
TÜV SÜD Product Service GmbH 0123 1 certificate
- V12 005092 0003 Withdrawn
Quality management system EU IVDR
- Issued
- 12 Jul 2022
- Expires
- 11 Jul 2027
- Reason
- Other
Related companies
Notified bodies
What Molecular Health GmbH makes
Molecular Health GmbH manufactures the MH Guide, a diagnostic device designed for molecular analysis in clinical settings. This tool supports the detection and analysis of genetic mutations, aiding in personalized medicine and targeted therapeutic approaches. It is primarily used in laboratory environments to assist in the identification of specific biomarkers relevant to oncology and other genetic disorders.
The MH Guide is classified as a Class C medical device under EU regulations, indicating a higher risk category requiring stringent conformity assessment. It is registered in the EUDAMED database, ensuring compliance with European Union Medical Device Regulations (MDR). The company is based in Germany.
Frequently asked questions
How many devices does Molecular Health GmbH have in the registry?
The registry currently lists 3 devices for Molecular Health GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Molecular Health GmbH's devices?
Among its 3 most recently registered devices, Molecular Health GmbH has devices listed in EUDAMED (3 devices).
What risk classes do Molecular Health GmbH's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Molecular Health GmbH's devices are IVDR Class C. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Molecular Health GmbH?
EUDAMED lists 1 certificate for Molecular Health GmbH (quality management system) under IVDR. The most recent was issued on 2022-07-12.
What are the newest devices from Molecular Health GmbH in the registry?
The most recently registered devices listed for Molecular Health GmbH include MH Guide.
Information
- Address
- 21, Kurfürsten-Anlage, Heidelberg, Germany
- Website
- www.molecularhealth.com/de
- [email protected]
- Phone
- +4915153850196
- PRRC contact
- Niels Dr. Bojunga
- EUDAMED SRN
- DE-MF-000012861