Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSafersonic Medizinprodukte GmbH
US
Last updated May 23, 2026
What Safersonic Medizinprodukte GmbH makes
Safersonic Medizinprodukte GmbH manufactures protective covers designed for ultrasound transducers, ensuring sterility and hygiene during sonography procedures. These covers are intended for single-use applications to maintain device integrity and reduce contamination risks during imaging.
The company’s products fall under Class II regulatory classification in the U.S., requiring premarket notification (510(k)) clearance through the FDA. The portfolio is listed under the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Safersonic Medizinprodukte GmbH manufacture?
Safersonic Medizinprodukte GmbH specializes in protective covers for ultrasound transducers. These covers are designed to maintain sterility and hygiene during sonography procedures, ensuring single-use applications to preserve device integrity and minimize contamination risks.
Where is Safersonic Medizinprodukte GmbH based?
The company is headquartered in the United States. This location influences its regulatory compliance, particularly under U.S. medical device laws.
Which regulatory registries list Safersonic’s devices?
Safersonic’s devices are listed under the FDA’s 510(k) registry. This registry tracks premarket notifications for Class II devices, which require clearance before commercial distribution in the U.S.
How are Safersonic’s devices classified under U.S. regulations?
The company’s products fall under Class II regulatory classification in the U.S. This classification applies to devices with moderate risk, requiring premarket notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Synergy MSK Ultrasound Strl Cover & Parker Gel | AR-3500-50D-US | FDA UDI | Class II | Active |
| Synergy MSK Ultrasound Strl Cover & Parker Gel | AR-3500-50D-US | FDA UDI | Class II | Active |
| Safersonic Sonography Cover | K092858 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.