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GYPSONA Splint System - Indonesia BPOM Medical Device Registration

GYPSONA Splint System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11402110469. The device is manufactured by BSN MEDICAL SA. OF. RESUME. from Mexico, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. ESSITY HYGIENE AND HEALTH INDONESIA.

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 : A
GYPSONA Splint System
Analysis ID: AKL 11402110469

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

Mexico

AR Address

Green Office Park 6, Wing B, lantai 1, Zona 8-12, BSD Green Office Park, BSD City, Desa Sampora, Kec. Cisauk, Kab.Tangerang 15345

Registration Date

Dec 16, 2020

Expiry Date

Nov 04, 2025

Product Type

Prosthetic Physical Health Equipment

External limb orthotic component.

Non Electromedic Non Sterile

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