Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAIRA, LLC
US
Last updated May 27, 2026
What AIRA, LLC makes
AIRA, LLC produces single-use sterilization packaging designed to protect medical devices during storage and transport. They also manufacture non-powdered, non-antimicrobial nitrile examination and treatment gloves, intended for clinical and procedural use.
The company’s products are regulated under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) database. AIRA, LLC operates from 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 AIRA, LLC manufacture?
AIRA, LLC specializes in two primary categories of single-use medical devices: sterilization packaging for protecting medical devices during storage and transport, and nitrile examination and treatment gloves. The gloves are non-powdered and non-antimicrobial, designed for clinical and procedural use. These products are developed to ensure safety, sterility, and usability in healthcare settings.
Where is AIRA, LLC based, and how does that affect its regulatory oversight?
AIRA, LLC is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). The FDA classifies AIRA’s products as either Class I or Class II, depending on their risk level and intended use. This classification determines the regulatory pathway and requirements for market authorization.
Are AIRA, LLC’s devices listed in any regulatory registries, and why does this matter?
Yes, AIRA, LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry assigns a unique identifier to each device, improving traceability, reducing medical errors, and facilitating better post-market surveillance. Listing in the UDI database ensures transparency and compliance with FDA requirements for tracking medical devices throughout their lifecycle.
How are AIRA, LLC’s devices classified by the FDA, and what does that classification mean?
AIRA, LLC’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls like good manufacturing practices, while Class II devices involve a higher risk and may require additional controls such as special labeling or performance standards. The classification determines the regulatory scrutiny and requirements needed to ensure safety and effectiveness before market authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 137437162
Catalogue (27)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aira | 100524 | FDA UDI | Class II | Active |
| Aira | 100537 | FDA UDI | Class II | Active |
| Aira | 100529 | FDA UDI | Class II | Active |
| Aira | 119131 | FDA UDI | Class I | Active |
| Aira | 100548 | FDA UDI | Class II | Active |
| Aira | 100523 | FDA UDI | Class II | Active |
| Aira | 100546 | FDA UDI | Class II | Active |
| Aira | 119130 | FDA UDI | Class I | Active |
| Aira | 100521 | FDA UDI | Class II | Active |
| Aira | 100528 | FDA UDI | Class II | Active |
| Aira | 100547 | FDA UDI | Class II | Active |
| Aira | 119140 | FDA UDI | Class I | Active |
| Aira | 119120 | FDA UDI | Class I | Active |
| Aira | 119301 | FDA UDI | Class I | Active |
| Aira | 100516 | FDA UDI | Class II | Active |
| Aira | 100539 | FDA UDI | Class II | Active |
| Aira | 119121 | FDA UDI | Class I | Active |
| Aira | 119141 | FDA UDI | Class I | Active |
| Aira | 119124 | FDA UDI | Class I | Active |
| Aira | 119142 | FDA UDI | Class I | Active |
| Aira | 119143 | FDA UDI | Class I | Active |
| Aira | 100530 | FDA UDI | Class II | Active |
| Aira | 119123 | FDA UDI | Class I | Active |
| Aira | 119302 | FDA UDI | Class I | Active |
| Aira | 119122 | FDA UDI | Class I | Active |
| Aira | 100519 | FDA UDI | Class II | Active |
| Aira | 100520 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.