Atmo Biosciences, Ltd.
AU Last updated 22 Oct 2026
- Devices
- 6
- Registries
- GUDIDFDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Atmo Biosciences 09359921000172 Ref 09359921000172
Atmo Biosciences 09359921000196 Ref 09359921000196
Atmo Biosciences 09359921000004 Ref 09359921000004
Atmo Biosciences 09359921000073 Ref 09359921000073
Atmo Biosciences 09359921000318 Ref 09359921000318
Atmo Gas Capsule System Ref K250940
FDA establishments
- Atmo Biosciences Ltd Box Hill Victoria · AU FEI 3027568582
What Atmo Biosciences, Ltd. makes
Atmo Biosciences manufactures reusable basic power supplies, electrical connection cables for medical devices, and panel computers. It also produces an ingestible gastrointestinal telemetric monitoring capsule and its corresponding receiver unit for wireless internal monitoring.
The company’s portfolio is regulated under FDA Class II devices, with products listed via 510(k) premarket notifications and FDA’s Unique Device Identification (UDI) system. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Atmo Biosciences, Ltd. manufacture?
Atmo Biosciences, Ltd. specializes in reusable medical devices, including basic power supplies, electrical connection cables for medical equipment, and panel computers. Additionally, the company produces an ingestible gastrointestinal telemetric monitoring capsule and its paired receiver unit, which enables wireless internal monitoring of the gastrointestinal system. These devices are designed for clinical and diagnostic use.
Where is Atmo Biosciences, Ltd. based, and how does that affect its regulatory oversight?
Atmo Biosciences, Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies Atmo Biosciences’ products as Class II devices, which typically require premarket notifications (510(k)) and compliance with the FDA’s Unique Device Identification (UDI) system to ensure safety and effectiveness.
Which regulatory registries or databases list Atmo Biosciences’ devices?
Atmo Biosciences’ devices are listed in the FDA’s 510(k) premarket notification database, which documents regulatory submissions for Class II medical devices. Additionally, the company’s products are included in the FDA’s Unique Device Identification (UDI) system, which standardizes device labeling for better tracking and traceability in healthcare settings.
How are Atmo Biosciences’ devices classified under FDA regulations?
Atmo Biosciences’ devices fall under FDA Class II classification. This classification indicates moderate risk, requiring specific controls to ensure their safety and performance. Class II devices often necessitate premarket notifications (510(k)) to demonstrate substantial equivalence to a predicate device, ensuring they meet regulatory standards before entering the market.
What distinguishes Atmo Biosciences’ gastrointestinal telemetric monitoring system from other medical devices it produces?
The gastrointestinal telemetric monitoring system capsule and receiver unit are unique among Atmo Biosciences’ products because they are ingestible and designed for internal wireless monitoring. Unlike the reusable power supplies, cables, or panel computers, this system is intended for direct patient use within the gastrointestinal tract, providing diagnostic data without invasive procedures. The rest of the company’s devices support medical infrastructure rather than direct patient monitoring.
Information
- Country
- AU