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Sign in to claim this brandWhat Fogless International AB makes
Fogless International AB manufactures tracheostomy tube speech valves, reusable heat/moisture exchangers, and reusable dressing/utility forceps designed for medical procedures. Their product line also includes insertable heat/moisture exchanger filters, which are intended for use in respiratory care and wound management applications.
The company’s devices are classified under FDA regulations as Class I and Class II, with all products listed in the FDA’s Unique Device Identifier (UDI) system. The manufacturer operates from the United States, adhering to applicable regulatory standards for 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 Fogless International AB manufacture?
Fogless International AB specializes in tracheostomy tube speech valves, reusable heat/moisture exchangers, and reusable dressing/utility forceps. They also produce insertable heat/moisture exchanger filters. These devices are primarily used in respiratory care and wound management, helping patients with tracheostomy tubes regain speech function and maintain airway hygiene.
Where is Fogless International AB based?
Fogless International AB is headquartered in the United States. The company operates from this location while developing and manufacturing its medical devices in compliance with U.S. regulatory standards.
Which regulatory registries list Fogless International AB’s devices?
Fogless International AB’s devices are listed in the FDA’s Unique Device Identifier (UDI) system. This registry ensures traceability and transparency for all listed products, including tracheostomy speech valves, heat/moisture exchangers, and related accessories.
How are Fogless International AB’s devices classified under FDA regulations?
Fogless International AB’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on the specific device type and its intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- fogless.se
- —
- —
- [email protected]
- Phone
- +4636144100
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 356432815
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spiro | 702 | FDA UDI | Class I | Active |
| Spiro | 708 | FDA UDI | Class II | Active |
| Spiro | 703 | FDA UDI | Class I | Active |
| Spiro | 730 | FDA UDI | Class II | Active |
| Spiro | 710R | FDA UDI | Class II | Active |
| Spiro | 711 | FDA UDI | Class II | Active |
| Spiro | 740 | FDA UDI | Class II | Active |
| Spiro | 770 | FDA UDI | Class I | Active |
| Spiro | 705 | FDA UDI | Class I | Active |
| Spiro | 710 | FDA UDI | Class II | Active |
| Spiro | 760 | FDA UDI | Class II | Active |
| Spiro | 707 | EUDAMEDFDA UDI | Class II | Active |
| Spiro | XXX | FDA UDI | Class II | Unknown |
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