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Sign in to claim this brandWhat VIO HEALTHTECH LIMITED makes
Vio HealthTech Limited manufactures thermometric fertility analysers designed to track basal body temperature for fertility monitoring. The devices provide continuous, wearable data to help users assess ovulation patterns and track reproductive cycles.
The company’s products are classified as Class II (U) devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Vio HealthTech Limited 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 Vio HealthTech Limited manufacture?
Vio HealthTech Limited specializes in thermometric fertility analysers, which are designed to monitor basal body temperature continuously. These devices help users track ovulation patterns and reproductive cycles by providing wearable data, enabling better fertility awareness.
Where is Vio HealthTech Limited based?
The company is headquartered in the United States. This location influences its regulatory compliance and market focus, particularly for devices intended for use in North America.
How are Vio HealthTech Limited’s devices classified under FDA regulations?
Vio HealthTech Limited’s devices are classified as Class II (U) under FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as fertility monitoring tools.
Are Vio HealthTech Limited’s devices listed in any regulatory registries?
Yes, Vio HealthTech Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps ensure traceability and transparency in the medical device supply chain, allowing for better tracking of device performance and compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ovusense.com
- —
- —
- [email protected]
- Phone
- +441926800502
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 347449352
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