Bosch Healthcare Solutions GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000024061 FEI 3001082393
- Devices
- 8
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Bosch Healthcare Solutions GmbH makes
The company produces electrochemical breath analysers intended for point-of-care use, including handheld devices and associated disposable components like filters and mouthpieces. These devices are designed for diagnostic testing, such as measuring breath carbon dioxide and oxygen levels, with some variants supporting specific clinical applications like respiratory monitoring.
The portfolio consists of Class II medical devices, regulated under FDA pathways including 510(k) clearance and the Unique Device Identifier (UDI) system. Products are listed in the US market and comply with relevant regulatory requirements for in vitro diagnostics (IVD).
Catalogue
Vivatmo pro-S Ref F09G100608
Regimes: CE IVDR Registry: EUDAMED- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Vivatmo pro-S Ref K243926
Regimes: 510(k) Registry: 510(k)Vivatmo pro Ref K233775
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- DE-MF-000024061
- FDA FEI number
- 3001082393
- DUNS number
- 341189007
- EU VAT number
- DE263309318
- EUDAMED status
- Active
- EUDAMED registered name
- Bosch Healthcare Solutions GmbH
- EUDAMED abbreviated name
- BHCS
- Registered address
- 50, Alte Bundesstraße, 71332, Waiblingen, Germany
- Website
- www.bosch-healthcare.com
- [email protected]
- Phone
- +49 711 811-0
- PRRC contact
- Carola Döffinger
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 15 Sep 2031
TÜV SÜD Product Service GmbH 0123 1 certificate
- V76 110139 0011 Active
Technical documentation EU IVDR
- Issued
- 16 Sep 2026
- Expires
- 15 Sep 2031
Frequently asked questions
How many devices does Bosch Healthcare Solutions GmbH have in the registry?
The registry currently lists 8 devices for Bosch Healthcare Solutions GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bosch Healthcare Solutions GmbH's devices?
Among its 8 most recently registered devices, Bosch Healthcare Solutions GmbH has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Bosch Healthcare Solutions GmbH's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Bosch Healthcare Solutions GmbH's devices are Class II and IVDR Class B. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Bosch Healthcare Solutions GmbH?
EUDAMED lists 1 certificate for Bosch Healthcare Solutions GmbH (technical documentation) under IVDR. 1 is recorded with the status issued. The most recent was issued on 16 Sep 2026.
What are the newest devices from Bosch Healthcare Solutions GmbH in the registry?
The most recently registered devices listed for Bosch Healthcare Solutions GmbH include Vivatmo pro-S, Spare part: Vivatmo pro handheld US F09G100602, Vivatmo pro Level 0 F09G100230 and Vivatmo pro F09G100510.