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Digital behind-the-ear (BTE) hearing aid. - Argentina Medical Device Registration

Access comprehensive regulatory information for Digital behind-the-ear (BTE) hearing aid. in the Argentina medical device market through Pure Global AI's free database. This Class I-II Registration Modification medical device is registered with Argentina's ANMAT (National Administration of Drugs, Food and Medical Technology). The device was registered on November 15, 2023.

This page provides complete registration details including product code (1478-86), brand name (Bernafon.), authorized representative information, registration type, and regulatory compliance data from the official Argentina ANMAT medical device database. Pure Global AI offers free access to Argentina's medical device registry, helping global MedTech companies navigate Argentina regulations efficiently.

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Argentina ANMAT Data
Bilingual (Spanish/English)
Class I-II Registration Modification
Digital behind-the-ear (BTE) hearing aid.
Audรญfono digital retroauricular (BTE).
Argentina Medical Device Registration
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Product Information

Leox 7/LX 7 BTE SP Leox 7 / LX7 BTE UP Leox 3 / LX 3 BTE SP Leox 3/LX3 BTE UP Nevara 1/NE1 CPx Nevara 1 / NE1 N Nevara 1 / NE1 NR Nevara 1 / NE1 P Nevara 1/NE1 PR Supremia 7/SR7 SP Supremia 3/SR3 SP Saw 9/VN9 B 105 Saw 7/VN7 B 105 They saw 5/VN5 B 105. Saw 3/VN3 B 105 They saw 1/VN1 B 105. Zerena 9 / ZR9 B 105 Zerena 7 / ZR7 B 105 Zerena 5 / ZR5 B 105 Zerena 3 / ZR3 B 105 Zerena 1 / ZR1 B 105 Alpha 9 / MNB T Alpha 9 / MNB T R Alpha 7 / MNB T Alpha 7 / MNB T R Alpha 5 / MNB T Alpha 5 / MNB T R Alpha 3 / MNB T Alpha 3 / MNB T R Alpha 1 / MNB T Alpha 1 / MNB T R Bernafon Alpha XT 9 MNB T Bernafon Alpha XT 7 MNB T Bernafon Alpha XT 5 MNB T Bernafon Alpha XT 9 MNB T R Bernafon Alpha XT 7 MNB T R Bernafon Alpha XT 5 MNB T R Enter A/Bernafon Enter A2 B 105 Enter A/Bernafon Enter A1 B 105

Spanish:

Leox 7 / LX 7 BTE SP Leox 7 / LX7 BTE UP Leox 3 / LX 3 BTE SP Leox 3 / LX3 BTE UP Nevara 1 / NE1 CPx Nevara 1 / NE1 N Nevara 1 / NE1 NR Nevara 1 / NE1 P Nevara 1 / NE1 PR Supremia 7 / SR7 SP Supremia 3 / SR3 SP Viron 9 / VN9 B 105 Viron 7 / VN7 B 105 Viron 5 / VN5 B 105 Viron 3 / VN3 B 105 Viron 1 / VN1 B 105 Zerena 9 / ZR9 B 105 Zerena 7 / ZR7 B 105 Zerena 5 / ZR5 B 105 Zerena 3 / ZR3 B 105 Zerena 1 / ZR1 B 105 Alpha 9 / MNB T Alpha 9 / MNB T R Alpha 7 / MNB T Alpha 7 / MNB T R Alpha 5 / MNB T Alpha 5 / MNB T R Alpha 3 / MNB T Alpha 3 / MNB T R Alpha 1 / MNB T Alpha 1 / MNB T R Bernafon Alpha XT 9 MNB T Bernafon Alpha XT 7 MNB T Bernafon Alpha XT 5 MNB T Bernafon Alpha XT 9 MNB T R Bernafon Alpha XT 7 MNB T R Bernafon Alpha XT 5 MNB T R Entra A / Bernafon Entra A2 B 105 Entra A / Bernafon Entra A1 B 105

Device Classification
Registration Type
Class I-II Registration Modification
Modificaciรณn de Registro Clase I-II
Product Code
1478-86
Brand Name
Bernafon.
Product Name
Digital behind-the-ear (BTE) hearing aid.
Audรญfono digital retroauricular (BTE).
Registration Information
Registration Date
November 15, 2023
Database ID
cmhazbf7x0dgbekwim25ll3io
Authorized Representative