ABLE Disposable Hemodialysis Access Catheter Set - Indonesia BPOM Medical Device Registration
ABLE Disposable Hemodialysis Access Catheter Set is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805513825. The device is manufactured by GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ORIONTAMA JAYA.
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
Manufacturer
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
ORIONTAMA JAYAAR Address
Jl. Sutomo No. 122-124, Medan
Registration Date
Jun 21, 2022
Expiry Date
Apr 06, 2027
Product Type
Therapeutic Gastroenterology-Urology Equipment
Blood access device and accessories.
Non Electromedic Sterile
VCATH Central Venous Catheter Kit-Double Lumen Compoundย Kit
VCATH Haemodialysis Catheter Kit-Double Lumen Standard Kit
VCATH Haemodialysis Catheter Kit-Double Lumen Compound Kit
ABLE Disposable Haemodialysers
ABRAMED Haemodialysis Catheter (HC)
ABRAMED Central Venous Catheter (CVC)
Vcath Haemodialysis Catheter Kit-Triple Lumen Standard Kit
SRI Disposable Fistula Needles
SRI Disposable Blood Lines
SRI Disposable Haemodialysers
MJBIO Drain Canister
GUANGDONG MEIJI BIOTECHNOLOGY CO., LTD.
LP-ESP Disc Prosthesis
SPINE INNOVATIONS
MJBIO Medical Negative Pressure Suction Device
GUANGDONG MEIJI BIOTECHNOLOGY CO., LTD.
MJBIO Vacuum Sealed Irrigation Wound Therapy Kit
GUANGDONG MEIJI BIOTECHNOLOGY CO., LTD.
KAPHORN Surgical Intruments
DISTIMP SAS
KAPHORN Spine Implants
DISTIMP SAS
VEOS Spine Implants
DISTIMP SAS
ABLE Disposable Abdomen Drainage Catheters
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD
ACIFBOX Surgical Instruments
DISTIMP SAS
ACIFBOX Spine Implants
DISTIMP SAS

