WINNER Silicone Face Mask - Indonesia BPOM Medical Device Registration
WINNER Silicone Face Mask is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10403917935. The device is manufactured by XIAMEN WINNER MEDICAL CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. SMORA SINAR SENTOSA.
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.
Risk Classification
Product Class
Kelas : 1
Manufacturer
XIAMEN WINNER MEDICAL CO., LTD.Country of Origin
China
Authorized Representative
PT. SMORA SINAR SENTOSAAR Address
Ruko Pamulang Asri Blok A1 RT.010 RW.004 Kel. Bambu Apus, Kec. Pamulang Tangerang selatan 15415
Registration Date
Nov 28, 2023
Expiry Date
Dec 27, 2026
Product Type
Therapeutic Anesthesia Equipment
Oxygen mask.
Non Electromedic Non Sterile

