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OTOPRONT - Indonesia BPOM Medical Device Registration

OTOPRONT is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20701320038. The device is manufactured by HAPPERSBERGER OTOPRONT GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. OPMIC PERKASA MANDIRI.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : B
OTOPRONT
Analysis ID: AKL 20701320038

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Germany

Authorized Representative

PT. OPMIC PERKASA MANDIRI

AR Address

Jl.Puri Kencana Blok K7-3D 3rd Fl Kembangan Jakarta 11610

Registration Date

Apr 16, 2024

Expiry Date

Mar 06, 2027

Product Type

Diagnostic Ear, Nose and Throat Equipment

Air or water caloric stimulator.

Non Radiation Electromedics

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