Ursatec GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000005353 FEI 3015789003
- Devices
- 32
- 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 Ursatec GmbH makes
Ursatec GmbH manufactures nasal sprays and drops containing isotonic or hypertonic saline solutions, often combined with additives like dexpanthenol, eucalyptus, menthol, or aloe vera. Products include formulations for sinus relief, hydration, and soothing nasal passages, such as sea salt-based sprays and drops with varying concentrations.
All listed devices fall under EU Medical Device Regulation Class I and are registered in the EUDAMED database. The company is based in Germany.
Catalogue
Search and filter all 32 devicesCompany details
- EUDAMED SRN
- DE-MF-000005353
- FDA FEI number
- 3015789003
- EU VAT number
- DE811479855
- EUDAMED status
- Active
- EUDAMED registered name
- Ursatec GmbH
- Registered address
- 4, Marpinger Weg, 66636, Tholey, Germany
- Website
- www.ursatec.com
- [email protected]
- Phone
- +49 6853 96199-0
- PRRC contact
- Andreas Bilstein
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 1 Aug 2028
ENTE CERTIFICAZIONE MACCHINE SRL 1282 1 certificate
- ECM23MDR002 Active
Quality management system EU MDR
- Issued
- 2 Aug 2023
- Expires
- 1 Aug 2028
Frequently asked questions
How many devices does Ursatec GmbH have in the registry?
The registry currently lists 32 devices for Ursatec GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ursatec GmbH's devices?
Among its 32 most recently registered devices, Ursatec GmbH has devices listed in EUDAMED (32 devices).
What risk classes do Ursatec GmbH's devices fall under?
Among its 32 most recently registered devices, the classes recorded for Ursatec GmbH's devices are Class I. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Ursatec GmbH?
EUDAMED lists 1 certificate for Ursatec GmbH (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2 Aug 2023.
What are the newest devices from Ursatec GmbH in the registry?
The most recently registered devices listed for Ursatec GmbH include Imidin® sanft Nasen-Pflegespray, Isotonic Nasal Spray with Sea Salt + 2% Dexpanthenol + Chamomile, Nasal Spray with Sea Salt + Eucalyptus and Nasal Spray with Trehalose.