COMPOLAB TM - Indonesia BPOM Medical Device Registration
COMPOLAB TM is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205420110. The device is manufactured by EKF-DIAGNOSTIC GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FRESENIUS KABI INDONESIA.
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
EKF-DIAGNOSTIC GMBHCountry of Origin
Germany
Authorized Representative
PT. FRESENIUS KABI INDONESIAAR Address
Menara Bidakara 1 Lt 19, Jl. Jend Gatot Subroto Kav 71-73
Registration Date
Jul 03, 2024
Expiry Date
Feb 20, 2029
Product Type
Automatic and Semi-Automatic Hematology Equipment
Automated hemoglobin system.
Invitro Diagnostics
CONOX Pediatric Sensor
FRESENIUS KABI (NANCHANG) CO., LTD.
FRESENIUS KABI 3 Way Stopcock
FRESENIUS KABI (NANCHANG) CO., LTD.
FRESENIUS 3-Way-Stopcock
CLINICO MEDICAL SP. Z.O.O.
AMICUS Separator and Accessories
FRESENIUS KABI WARRENDALE.
VS 10 DEHP-Free
CLINICO MEDICAL SP. Z O.O.
AmiCORE Apheresis Kit - Single Needle with Two Platelet Containers and PAS Connector
FENWAL INTERNATIONAL, INC.
FRESENIUS Amicore Apheresis Kit - Single Needle
FENWAL INTERNATIONAL INC.
AGILIA SP PCA WIFI ID
FRESENIUS VIAL
AMICORE Apheresis Kit - Single Needle with Two Platelet Containers
FENWAL INTERNATIONAL INC.
COMPOLAB TM Cuvette
EKF-DIAGNOSTIC GMBH

