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US
Last updated May 31, 2026
What OXUS AMERICA, INC. makes
Oxus America, Inc. manufactures mobile and portable oxygen concentrators designed for use outside clinical settings, including refurbished sieve-bed models and variants branded under the Oxus/GCE line. These devices filter ambient air to deliver concentrated oxygen, intended for patients requiring oxygen therapy in non-hospital environments.
The company’s products fall under FDA Class II regulation and are listed in the FDA’s Unique Device Identifier (UDI) database. Oxus America, Inc. 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 Oxus America, Inc. manufacture?
Oxus America, Inc. specializes in mobile and portable oxygen concentrators. These devices are designed to filter ambient air and deliver concentrated oxygen for patients needing therapy outside clinical settings, such as at home or while traveling. The company’s portfolio includes both refurbished sieve-bed models and variants under the Oxus/GCE brand.
Where is Oxus America, Inc. based?
Oxus America, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support, particularly for its Class II devices.
Which regulatory registries or databases list Oxus America, Inc.’s devices?
Oxus America, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II medical devices, including the company’s portable oxygen concentrators, by assigning standardized identifiers for tracking and compliance.
How are Oxus America, Inc.’s devices classified under FDA regulations?
Oxus America, Inc.’s devices fall under FDA Class II classification. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- oxusamerica.com
- —
- —
- [email protected]
- Phone
- 248-475-0925
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 962894098
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Oxus Refurbished Sieve Bed | RS-07001/RS-07002 | FDA UDI | Class II | Active |
| Oxus / GCE | RS-00502C | FDA UDI | Class II | Active |
| Oxus / GCE | RS-00500 | FDA UDI | Class II | Active |
| Oxus / GCE | RS-00600 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Oxus America, Inc. has one FDA recall record initiated on January 14, 2013, which is marked as terminated. The recall was due to potential over-discharge of batteries caused by past storage conditions and deficiencies in maintenance procedures.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 14, 2013 | Z-0768-2013 | — | terminated | Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells. |