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Sign in to claim this brandWhat Tomed GmbH makes
Tomed GmbH manufactures mandible-repositioning orthoses designed to treat sleep-disordered breathing, including devices like the SomnoGuard SP Pro, SomnoGuard AP 2, and SomnoGuard SP Soft. These products are custom-fitted oral appliances that reposition the jaw to improve airway patency during sleep.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Tomed GmbH operates with a US presence, adhering to applicable regulatory standards for these medical devices.
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 Tomed GmbH manufacture?
Tomed GmbH specializes in mandible-repositioning sleep-disordered breathing orthoses, which are custom-fitted oral appliances. These devices reposition the jaw to help improve airway patency during sleep, primarily targeting conditions like obstructive sleep apnea. Examples include the SomnoGuard SP Pro, SomnoGuard AP 2, and SomnoGuard SP Soft.
Where is Tomed GmbH based, and does it operate in the US?
Tomed GmbH has a US presence, meaning it operates within the United States. While the company’s headquarters may be located elsewhere, its regulatory activities and device listings (such as UDI entries) reflect compliance with US standards for medical devices.
How are Tomed GmbH’s devices classified under FDA regulations?
Tomed GmbH’s mandible-repositioning orthoses are classified as Class II devices under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls (such as performance standards or post-market surveillance) to ensure safety and effectiveness.
Are Tomed GmbH’s devices listed in any regulatory databases?
Yes, Tomed GmbH’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system is mandatory for Class II devices in the US, ensuring traceability and transparency in the regulatory and healthcare supply chains.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 313000292
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SomnoGuard SP Pro | 03100000 | FDA UDI | Class II | Active |
| SomnoGuard AP 2 | 03050200 | FDA UDI | Class II | Active |
| SomnoGuard SP Soft | 03070000 | FDA UDI | Class II | Active |
| SomnoGuard SPX | 03090000 | FDA UDI | Class II | Active |
| SomnoGuard AP Pro | 03060000 | FDA UDI | Class II | Active |
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