MKCELLS Hollow Fiber Dialyzer - Indonesia BPOM Medical Device Registration
MKCELLS Hollow Fiber Dialyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805420307. The device is manufactured by SHANDONG WEIGAO BLOOD PURIFICATION PRODUCTS 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
Country of Origin
China
Authorized Representative
PT. INTERSKALA SEHAT SEJAHTERAAR Address
INTERSKALA SEHAT SEJAHTERA
Registration Date
Jun 10, 2024
Expiry Date
Jun 08, 2027
Product Type
Therapeutic Gastroenterology-Urology Equipment
Hemodialysis system and accessories.
Non Electromedic Sterile
WEGO Extracorporeal Blood Circuit for Blood Purification Equipment
WEGO A.V. Fistula Needle Sets
WEGO Middle-Flux Hollow Fiber Dialyzer (MF Series)
WEGO Low-Flux Hollow Fiber Dialyzer
WEGO Hollow Fiber Hemodiafiltration ( HDF Series )
WEGO High-Flux Hollow Fiber Dialyzer (E Series)
WEGO Hollow Fiber Dialyzer HF series
CC MEDICAL A.V. Fistula Needle Sets
CC MEDICAL Hollow Fiber Dialyzer
CC MEDICAL Extracorporeal Blood Circuit of Blood Purification Equipment
MKCELLS Bicarbonate B
TIANJIN TAISHIKANG PHARMACEUTICAL TECHNOLOGY CO., LTD.
MKCELLS CA-150 Auto Chemistry Analyzer and Accessories
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MKCELLS A.V. Fistula Needle Sets
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MKCELLS Hematology Analyzer Control (Level 1)
MACCURA BIOTECHNOLOGY CO., LTD.
MKCELLS Disposable Blood Specimen Collection Needle
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MKCELLS Hematology Analyzer Calibrator
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MKCELLS Hematology Analyzer Control (Level 2)
MACCURA BIOTECHNOLOGY CO., LTD.
MKCELLS Hematology Analyzer Control (Level 3)
MACCURA BIOTECHNOLOGY CO., LTD.
MKCELLS Lactate Dehydrogenase (LDH) Assay Kit (Lactic Acid Substrates Method)
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MKCELLS Disposable Butterfly Blood Collection Needle
JIANGSU KANGJIE MEDICAL DEVICES CO., LTD.

