CARDIOHELP-i - Indonesia BPOM Medical Device Registration
CARDIOHELP-i is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20504810509. The device is manufactured by MAQUET CARDIOPULMONARY LTD. from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is INDOSOPHA SAKTI.
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
MAQUET CARDIOPULMONARY LTD.Country of Origin
Germany
Authorized Representative
INDOSOPHA SAKTIAR Address
JL. MAMPANG PRAPATAN RAYA NO.1
Registration Date
Dec 24, 2024
Expiry Date
Dec 31, 2025
Product Type
Surgical Cardiology Equipment
Cardiopulmonary bypass heart-lung machine console.
Non Radiation Electromedics
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