Pure Global

GYMNA Ultrasound Compact - Indonesia BPOM Medical Device Registration

GYMNA Ultrasound Compact is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21403420432. The device is manufactured by GYMNAUNIPHY N.V. from Belgium, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SIX COLORS OF MEDICINE.

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
GYMNA Ultrasound Compact
Analysis ID: AKL 21403420432

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

GYMNAUNIPHY N.V.

Country of Origin

Belgium

Authorized Representative

PT. SIX COLORS OF MEDICINE

AR Address

Ruko Grand Galaxy City Bekasi Blok RSN 2 No.5

Registration Date

Nov 09, 2024

Expiry Date

Jan 11, 2028

Product Type

Therapeutic Physical Health Equipment

Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing