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Sign in to claim this brandONY BIOTECH INC.
US
Last updated September 17, 2026
What ONY BIOTECH INC. makes
Ony Biotech Inc. manufactures single-use oropharyngeal airway devices. Their product line includes the AerVia Neonatal Supraglottic Airway Device, which is available in various sizes designed for neonates ranging from under 1000g to 5000g.
These devices are classified as Class I medical devices and are based in the United States. The product portfolio is listed within the FDA UDI database.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of medical devices does Ony Biotech Inc. manufacture?
Ony Biotech Inc. specializes in the production of single-use oropharyngeal airway devices. Their primary product line is the AerVia Neonatal Supraglottic Airway Device, which is specifically engineered in multiple sizes to support neonates weighing from under 1000g up to 5000g.
Where is Ony Biotech Inc. based?
Ony Biotech Inc. is based in the United States. This location information is provided as part of the company's profile to identify its primary operational base.
How are the devices from Ony Biotech Inc. classified?
The devices manufactured by Ony Biotech Inc. are classified as Class I medical devices. This classification is based on the regulatory designation assigned to their specific product line of oropharyngeal airway devices.
Which registries list the devices produced by Ony Biotech Inc.?
The devices manufactured by Ony Biotech Inc. are listed within the FDA UDI database. This registry serves as the official source for identifying the company's medical devices and their associated regulatory information.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 455 Commerce Dr, Amherst, NY, 14228
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 1319086
- DUNS Number
- —
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AerVia Neonatal Supraglottic Airway Device, Small, <1000g | AVSmall | FDA UDI | Class I | Active |
| AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g | AVLarge | FDA UDI | Class I | Active |
| AerVia Neonatal Supraglottic Airway Device, Medium, 1000-2000g | AVMed | FDA UDI | Class I | Active |
| AerVia Neonatal Supraglottic Airway Device, Variety | AVVariety | FDA UDI | Class I | Active |
| AerVia Neonatal Supraglottic Airway Device, X-Large, 3500-5000g | AVXL | FDA UDI | Class I | Active |
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