Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat Saxony Beauty Technology GmbH makes
Saxony Beauty Technology GmbH manufactures hand-held electric massagers designed for personal use, including models like the stratosphere and Dr. Blitz. These devices are intended for muscle relaxation and pain relief through vibration and massage techniques.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. 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 Saxony Beauty Technology GmbH manufacture?
Saxony Beauty Technology GmbH specializes in hand-held electric massagers for personal use. These devices, such as the stratosphere and Dr. Blitz models, are designed to provide muscle relaxation and pain relief through vibration and massage functions. The company focuses exclusively on this category of Class I devices.
Where is Saxony Beauty Technology GmbH based?
The company is headquartered in the United States. This location determines its regulatory jurisdiction under U.S. medical device laws, including classification and listing requirements.
Which regulatory registries or databases list Saxony Beauty Technology GmbH’s devices?
Saxony Beauty Technology GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices like their hand-held electric massagers, such as the stratosphere and Dr. Blitz.
How are Saxony Beauty Technology GmbH’s devices classified under U.S. regulations?
The company’s hand-held electric massagers, including models like stratosphere and Dr. Blitz, are classified as Class I medical devices under FDA regulations. This classification applies due to their low-risk nature for personal use, requiring minimal premarket scrutiny but still mandating compliance with general controls and UDI listing.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- [email protected]
- Phone
- +17028880889
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 313345439
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| stratosphere | CelluShot | FDA UDI | Class I | Active |
| stratosphere | 24 | FDA UDI | Class I | Active |
| Dr. Blitz | Solo | FDA UDI | Class I | Active |
| stratosphere | Smart | FDA UDI | Class I | Active |
| stratosphere | Solo | FDA UDI | Class I | Active |
| Dr. Blitz | Face | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.