Orbisana Healthcare GmbH
Inactive in EUDAMED since 2026Germanyfrom SRN EUDAMED FDA SRN DE-MF-000023387 FEI 3002345941
Inactive. This company's EUDAMED actor record is marked inactive. Check the current status before ordering.
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
0 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Orbisana Healthcare GmbH makes
Orbisana Healthcare GmbH manufactures medical accessories for intravenous (IV) administration, including the SERVOX Verschlusskappe 22, a protective cap designed to seal IV ports, and the SERVOX 22 and 15 Adapter, which facilitate connections between IV lines and ports of varying sizes. These products are intended for use in hospital and clinical settings to ensure secure and contamination-free fluid pathways during patient care.
The company’s products fall under EU Medical Device Regulation Class I, indicating low-risk devices requiring conformity assessment procedures. These devices are registered in the EU’s eudamed database, ensuring compliance with European Union medical device regulations. The manufacturer is based in Germany.
Catalogue
SERVOX Verschlusskappe 22 Ref 25058
Regimes: CE MDR, withdrawn Registry: EUDAMEDSERVOX 22, 15 Adapter Ref 26912
Regimes: CE MDR, withdrawn Registry: EUDAMED
Company details
- EUDAMED SRN
- DE-MF-000023387
- FDA FEI number
- 3002345941
- EU VAT number
- DE 122950345
- EUDAMED status
- Inactive since 2026
- EUDAMED registered name
- Orbisana Healthcare GmbH
- Registered address
- 24 - 26, Biberweg, 53831, Troisdorf, Germany
- Website
- www.orbisana.de
- [email protected]
- Phone
- +49 2241 9322-0
- PRRC contact
- Christoph Bernads
EUDAMED certificates
1 certificate0 valid, 0 expired, 1 withdrawn or suspendedMDR 1
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 1396541-1 Cancelled
Quality management system EU MDR
- Issued
- 25 Sep 2024
- Expires
- 24 Sep 2029
- Reason
- Other
Frequently asked questions
How many devices does Orbisana Healthcare GmbH have in the registry?
The registry currently lists 2 devices for Orbisana Healthcare GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orbisana Healthcare GmbH's devices?
Among its 2 most recently registered devices, Orbisana Healthcare GmbH has devices listed in EUDAMED (2 devices).
What risk classes do Orbisana Healthcare GmbH's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Orbisana Healthcare GmbH's devices are Class I. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Orbisana Healthcare GmbH?
EUDAMED lists 1 certificate for Orbisana Healthcare GmbH (quality management system) under MDR. The most recent was issued on 25 Sep 2024.
What are the newest devices from Orbisana Healthcare GmbH in the registry?
The most recently registered devices listed for Orbisana Healthcare GmbH include SERVOX Verschlusskappe 22 and SERVOX 22,15 Adapter.