Vietnam MOH registration 240001347/PCBB-HCM

Auditory Evoked Potential and Cochlear Implant (Hearing Screening)

VN: Máy đo điện thính giác và âm ốc tai (sàng lọc khiếm thính)

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Interacoustics A/S, Denmark·Registered Jun 28, 2024

Registration details

Analysis ID: 240001347/PCBB-HCM
Submission ID: 000.00.19.H29-240624-0011
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Interacoustics A/S, Denmark
Manufacturer Country: Theo theo phụ lục
Product Owner: Interacoustics A/S, Denmark
Authorized Representative: CÔNG TY TNHH DỊCH VỤ TRỢ THÍNH QUANG ĐỨC

Technical details

Intended Use: Use auditory screening to detect hearing impairment, and assess the function of the vestibular system.

Dates and status

Registration Date: Jun 28, 2024

About this record

Access comprehensive regulatory information for Auditory Evoked Potential and Cochlear Implant (Hearing Screening) 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 240001347/PCBB-HCM and manufactured by Interacoustics A/S, Denmark. The authorized representative in Vietnam is CÔNG TY TNHH DỊCH VỤ TRỢ THÍNH QUANG ĐỨC.

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