Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signs
Hyperbaric chambers
EMDN code Z120308
Manufacturers registered in Europe (EUDAMED) 14
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 19
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Perry Baromedical Corp. | United States | Perry Sigma Monoplace Baramed Perry Baromedical | K072427 (2008) |
| HYPERBARIC TECHNOLOGIES, INC. | United States | Vitaeris 320 Quamvis Lite 320 Gamow Ultra-Lite Solace 210 Gamow Bag Quamvis 270 | K011866 (2002) |
| TEKNA MANUFACTURING PRIVATE LIMITED | – | TEKNA Manufacturing Pvt. Ltd. | registered |
| TYPHOON WATER WARES LTD | United States | Newtowne Hyperbarics Newtowne Tent Chamber | registered |
| Hyperbaric Modular Systems Inc. | United States | HMS-2000 HMS-5000-COMPACT-QUADRO HMS-5000 HMS-5000-6-MINI-QUADRO HMS-4000 HMS-1000 | registered |
| FINK ENGINEERING PTY LTD | Australia | Multiplace Hyperbaric Oxygen Treatment Chamber | K240569 (2024) |
| PCCI HYPERBARIC SYSTEMS | – | PCCI Hyperbaric Systems | registered |
| SUMMIT TO SEA, LLC | United States | Summit to Sea | K072757 (2008) |
| Hyperbaric For Life.com, Llc | – | Hyperbaric for Life | registered |
| Environmental Tectonics Corp. | United States | Baramed Hyperbaric Chamber | K092991 (2010) |
| Pan-America Hyperbarics, Inc. | United States | PAHI PAH-S1 Monoplace Hyperbaric Chamber | K021690 (2002) |
| Sea-Long Medical Systems LLC | United States | Sea-Long Medical Hood | K010659 (2001) |
| US Hyperbaric Network LLC | United States | US Hyperbaric Network | K220290 (2023) |
| AHA Hyperbarics GMBH | Austria | – | registered |
| Hyperbaric For Life, LLC | United States | – | K041007 (2004) |
| Hyperbaric S.A.C. | Peru | – | registered |
| Oxyheal Medical Systems, Inc. | United States | – | K163109 (2017) |
| PCCI, INC | United States | – | registered |
| SOS Group GBR Ltd. | United Kingdom | – | registered |
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