HELENA Actalyke Clotting Time Test System MAX-ACT - Indonesia BPOM Medical Device Registration
HELENA Actalyke Clotting Time Test System MAX-ACT is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207013761. The device is manufactured by HELENA LABORATORIES. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ABADINUSA USAHASEMESTA.
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
HELENA LABORATORIES.Country of Origin
United States
Authorized Representative
ABADINUSA USAHASEMESTAAR Address
Jalan Raden Saleh No. 45 G
Registration Date
Dec 05, 2023
Expiry Date
Dec 31, 2025
Product Type
Haematology Package and Kit
Activated whole blood clotting time tests.
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