ADVITOS GmbH
Germany DE-MF-000012040 Last updated 21 Oct 2026
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- Devices
- 6
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
ADVOS GluCAp Ref 1007580
NaCl-Concentrate Ref 1001543
ADVOS Hämodialysesystem Ref 1007400-AB
ADVOS procedure pack Ref 1004207
ADVOS Hämodialysesystem Ref 1007400
ADVOS Befüllsystem Ref 1007476
EUDAMED certificates
TÜV SÜD Product Service GmbH 0123 1 certificate
- G15 064517 0014 Supplemented
Quality management system EU MDR
- Issued
- 16 Jun 2026
- Expires
- 28 Feb 2029
- Reason
- Add device or group
Related companies
Notified bodies
About
ADVITOS ADVOS is a certified innovation for the treatment of multi-organ failure in intensive care units.
What ADVITOS GmbH makes
ADVITOS GmbH manufactures medical devices for use in intensive care settings, including procedure packs for specialized interventions, hemodialysis systems for blood filtration, and filling systems designed for preparing dialysis solutions. These products are intended to support critical care treatments, particularly for patients with multi-organ failure.
The company’s devices fall under EU Class IIb classification and are registered in the EU’s eudamed database. ADVITOS GmbH is based in Germany.
Frequently asked questions
What types of medical devices does ADVITOS GmbH manufacture?
ADVITOS GmbH develops medical devices specifically designed for intensive care environments. Their portfolio includes procedure packs for specialized interventions, hemodialysis systems used to filter blood during treatment, and filling systems for preparing dialysis solutions. These devices are engineered to assist in critical care, particularly for patients experiencing multi-organ failure.
Where is ADVITOS GmbH based?
ADVITOS GmbH is headquartered in Germany, where it operates as a manufacturer of medical devices tailored for intensive care applications.
Which regulatory registries list ADVITOS GmbH’s devices?
ADVITOS GmbH’s devices are registered in the eudamed database, which is the European Union’s central registry for medical devices. This listing ensures transparency and compliance with EU regulatory requirements.
How are ADVITOS GmbH’s devices classified under EU regulations?
ADVITOS GmbH’s devices fall under EU Class IIb classification. This classification is assigned based on risk assessment criteria, where Class IIb devices pose moderate to high risks and require additional scrutiny to ensure safety and performance, such as through clinical evaluations or designated conformity assessment procedures.
Information
- Country
- Germany
- Address
- 1, Agnes-Pockels-Bogen, München, Germany
- Website
- www.advitos.com
- [email protected]
- Phone
- +49 (89) 4111842-00
- EUDAMED SRN
- DE-MF-000012040