ZENER Orthopaedic External Fixation System - Indonesia BPOM Medical Device Registration
ZENER Orthopaedic External Fixation System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302020454. The device is manufactured by CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD.. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ADHIRA MEDIKA PERSADA INTERNATIONAL.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD..Country of Origin
China
Authorized Representative
PT. ADHIRA MEDIKA PERSADA INTERNATIONALAR Address
Ruko Paramount Sparks B No. 17, Jl. Raya Kelapa Dua Gading Serpong
Registration Date
Feb 14, 2020
Expiry Date
Sep 25, 2024
Product Type
Prosthetic Orthopedic Equipment
Single/multiple component metallic bone fixation appliances and accessories.
Non Electromedic Non Sterile
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ZENER MEDTEC (CHANGZHOU) CO.,LTD
ZENER Metallic Bone Plate System 1
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ZENER Metallic Bone Screw System 2
ZENER MEDTEC (CHANGZHOU) CO., LTD.
ZENER Metallic Intramedullary Nails System
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ZENER Metallic Bone Plate System 3
ZENER MEDTEC (CHANGZHOU) CO.,LTD
ZENER Metallic Bone Plate System 2
ZENER MEDTEC (CHANGZHOU) CO.,LTD
ZENER Kyphoplasty Tool Kit
ZENER MEDTEC (CHANGZHOU) CO., LTD.
ZENER GENERAL SPINAL SYSTEM 2
ZENER MEDTEC (CHANGZHOU) CO., LTD.
ZENER GENERAL SPINAL SYSTEM
ZENER MEDTEC (CHANGZHOU) CO., LTD.
ITI Knee Joint Prosthesis System
BEIJING AK MEDICAL CO., LTD

