MKCELLS Disposable Hemoperfutor - Indonesia BPOM Medical Device Registration
MKCELLS Disposable Hemoperfutor is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805320711. The device is manufactured by CHENGDU OCI MEDICAL DEVICES CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. INTERSKALA SEHAT SEJAHTERA.
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
CHENGDU OCI MEDICAL DEVICES CO., LTD.Country of Origin
China
Authorized Representative
PT. INTERSKALA SEHAT SEJAHTERAAR Address
INTERSKALA SEHAT SEJAHTERA
Registration Date
May 16, 2023
Expiry Date
Feb 22, 2026
Product Type
Therapeutic Gastroenterology-Urology Equipment
Sorbent hemoperfusion system
Non Radiation Electromedics
CRONOS High-Flux Polyethersulfone Hollow Fiber Hemodialyzer
CRONOS Low-Flux Polyethersulfone Hollow fiber Hemodialyzer
PURIFIER Polyethersulfone Hollow Fiber Hemodialyzer
MLH Hollow Fiber Membrane Hemodialyzer
DCPro-9 Blood Tubing Set
DCPro-9 AV Fistula Needles
DCPro-9 High Flux Polyethersulfone Hollow Fiber Hemodialyzer
OCI Hollow Fiber Dialyzer
OCI Hemodialysis Blood Tubing Sets
OCI Arteriovenous Fistula Needle Sets
MKCELLS Bicarbonate B
TIANJIN TAISHIKANG PHARMACEUTICAL TECHNOLOGY CO., LTD.
MKCELLS CA-150 Auto Chemistry Analyzer and Accessories
SHENZHEN HETO MEDICAL TECH CO.,LTD.
MKCELLS Hollow Fiber Dialyzer
SHANDONG WEIGAO BLOOD PURIFICATION PRODUCTS CO., LTD.
MKCELLS A.V. Fistula Needle Sets
SHANDONG WEIGAO BLOOD PURIFICATION PRODUCTS CO., LTD.
MKCELLS Hematology Analyzer Control (Level 1)
MACCURA BIOTECHNOLOGY CO., LTD.
MKCELLS Hematology Analyzer Calibrator
MACCURA BIOTECHNOLOGY CO., LTD.
MKCELLS Hematology Analyzer Control (Level 2)
MACCURA BIOTECHNOLOGY CO., LTD.
MKCELLS Hematology Analyzer Control (Level 3)
MACCURA BIOTECHNOLOGY CO., LTD.
MKCELLS Disposable Blood Specimen Collection Needle
JIANGSU KANGJIE MEDICAL DEVICES CO., LTD.
MKCELLS Lactate Dehydrogenase (LDH) Assay Kit (Lactic Acid Substrates Method)
BEIJING STRONG BIOTECHNOLOGIES, INC.