Auditory Evoked Potential Tester - Vietnam Registration 240000548/PCBB-HCM

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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240000548/PCBB-HCM

Registration Details

Vietnam MOH Registration: 240000548/PCBB-HCM

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Device Details

Auditory Evoked Potential Tester

VN: Máy đo thính lực

Risk Class TTBYT Loại B

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

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.