ONEHEALTH STERILE SURGICAL BLADES - Indonesia BPOM Medical Device Registration
ONEHEALTH STERILE SURGICAL BLADES is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11603324670. The device is manufactured by HUAIAN TIANDA MEDICAL INSRUMENT CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. MEDICAL ERA ALKESINDO.
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
HUAIAN TIANDA MEDICAL INSRUMENT CO., LTD.Country of Origin
China
Authorized Representative
PT. MEDICAL ERA ALKESINDOAR Address
Jl. Sisingamangaraja Kilometer 10.8, Komplek Amplas Trade Centre Blok Mahoni nomor 08, Kota Medan, Provinsi Sumatera Utara, Kode Pos: 20148
Registration Date
Aug 11, 2023
Expiry Date
Aug 09, 2026
Product Type
Surgical Equipment
Manual surgical instrument for general use.
Non Electromedic Sterile
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