Polysomnography System
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Neurotronics, LLC·Registered May 13, 2024- Analysis ID
- 240001062/PCBB-HN
- Submission ID
- 000.00.19.H26-240513-0004
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Neurotronics, LLC
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Neurotronics, LLC
- Authorized Representative
- CÔNG TY CỔ PHẦN Y TẾ NOVOMED
- Intended Use
- The Sphinx PMU710 is designed to be used with the polysomnography measurement system. The Sphinx PMU710 is designed to measure, amplify, and record the physiological signals collected from the patient to be stored in the sleep study. The physiological signals are recorded and adjusted for analysis and display. Qualified sleep clinical doctors can analyze the data in real-time or offline on the specialized polysomnography software running on a personal computer to help diagnose sleep disorders. The Sphinx PMU710 is designed to be used by medical professionals in hospitals, laboratories, clinics, or nursing homes; or outside medical facilities under the direct supervision of medical professionals.
- Registration Date
- May 13, 2024
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Access comprehensive regulatory information for Polysomnography System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001062/PCBB-HN and manufactured by Neurotronics, LLC. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ NOVOMED.
This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including SOMNOmedics GmbH, Neurotronics, LLC, and 3 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.