Pure Global

OTICON XCEED 1 BTE UP - Indonesia BPOM Medical Device Registration

OTICON XCEED 1 BTE UP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20702420020. The device is manufactured by SBO HEARING A/S from Denmark, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. KASOEM HEARING.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
OTICON XCEED 1 BTE UP
Analysis ID: AKL 20702420020

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SBO HEARING A/S

Country of Origin

Denmark

Authorized Representative

PT. KASOEM HEARING

AR Address

Jl. Setiabudi No. 34, RT 002 RW 003, Kel. Hegarmanah, Kec. Cidadap, Kota Bandung, Jawa Barat

Registration Date

Feb 13, 2024

Expiry Date

Oct 23, 2028

Product Type

Prosthetic Ear, Nose and Throat Equipment

Wireless air-conduction hearing aid

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing