Hydraulic Penile Implant - Indonesia BPOM Medical Device Registration
Hydraulic Penile Implant is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30803120102. The device is manufactured by ZEPHYR SURGICAL IMPLANTS SARL from Switzerland, and is classified as Risk Class Kelas Resiko : D. 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 : 3
Manufacturer
ZEPHYR SURGICAL IMPLANTS SARLCountry of Origin
Switzerland
Authorized Representative
PT. EDISON AMBASSADOR MEANSAR Address
Jl. Oasis Sememi Raya No. 1 RT 01 RW 04
Registration Date
Jan 08, 2021
Expiry Date
May 27, 2025
Product Type
Prosthetic Gastroenterology-Urology Equipment
Penile inflatable implant.
Non Electromedic Sterile
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.

