NEW ELEMENT Electromagnetic Extracorporeal Shock Wave Lithotripter - Indonesia BPOM Medical Device Registration
NEW ELEMENT Electromagnetic Extracorporeal Shock Wave Lithotripter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805022393. The device is manufactured by SHENZHEN NEW ELEMENT MEDICAL EQUIPMENT TECHNOLOGY DEVELOPMENT CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. EDISON AMBASSADOR MEANS.
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 : 2
Country of Origin
China
Authorized Representative
PT. EDISON AMBASSADOR MEANSAR Address
Jl. Oasis Sememi Raya No. 1 RT 01 RW 04
Registration Date
May 03, 2021
Expiry Date
Jan 19, 2026
Product Type
Therapeutic Gastroenterology-Urology Equipment
Extracorporeal shock wave lithotripter.
Non Radiation Electromedics
MEDNOVA Single Use Stone Retrieval Balloons
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD
EDISON Video Laryngoscope
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD
MEDNOVA Polypectomy Snare (Cold Snare)
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
EDISON Single-use Choledochoscope
SHENZEN HUGEMED MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
EDISON Single - Use Cystoscope
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
TAIWAN SURGICAL INNO-HOOK Reusable Clip Applier
TAIWAN SURGICAL CORPORATION
PLASTI-MED Breathing Circuit Coaxial - Adult
PLASTI-MED PLASTIC MEDICAL PRODUCTS SAN. TIC. LTD. STI
PLASTI-MED Breathing Circuit Coaxial - Adult
PLASTI-MED PLASTIC MEDICAL PRODUCTS SAN. TIC. LTD. STI
BOLY Electric Saw Drill BLJZ-1
NINGBO BOLY MEDICAL EQUIPMENT CO., LTD.
MEDNOVA Hot Biopsy Forceps
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.