Vietnam MOH registration 240000548/PCBB-HCM

Auditory Evoked Potential Tester

VN: Máy đo thính lực
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Amplivox Ltd·Registered Mar 12, 2024
Registration details
Analysis ID
240000548/PCBB-HCM
Submission ID
000.00.19.H29-240302-0002
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer
Amplivox Ltd
Manufacturer Country
Theo theo phụ lục
Product Owner
Amplivox Ltd
Authorized Representative
CÔNG TY TNHH Y TẾ LƯ GIA
Technical details
Intended Use
The audiometer is designed for audiologists, healthcare specialists, hearing aid consultants, and pediatricians. The device can measure air and bone conduction, measure both covered and uncovered, and has multiple functions to support direct or recorded speech audiometry, free-field measurements with headphones and speech audiometry, and various clinical audiometric tests.
Dates and status
Registration Date
Mar 12, 2024
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About this record

Access comprehensive regulatory information for Auditory Evoked Potential Tester 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 240000548/PCBB-HCM and manufactured by Amplivox Ltd. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ LƯ GIA.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Theo theo phụ lục, SIBEL, S.A.U., and 5 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.

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