Pure Global

SERENITY Medical Respiratory Mask - Indonesia BPOM Medical Device Registration

SERENITY Medical Respiratory Mask is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20903025041. The device is manufactured by SHANDONG HAIDIKE MEDICAL CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SERENITY 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
SERENITY Medical Respiratory Mask
Analysis ID: AKL 20903025041

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. SERENITY INDONESIA

AR Address

Komplek Ruko Permata Kota Blok Q No. 10 Jl. Pangeran Tubagus Angke No.170 RT.010 RW . 01

Registration Date

Aug 28, 2024

Expiry Date

Aug 25, 2025

Product Type

General Hospital Equipment and Other Individuals

Filtering facepiece respirator for use by the general public in public health medical emergencies.

Non Electromedic Non Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing