CARESCAPE Monitor B850 - Indonesia BPOM Medical Device Registration
CARESCAPE Monitor B850 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501712160. The device is manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES - CRITIKON DE MEXICO S. DE R.L. DE C.V. from Mexico, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. GE OPERATIONS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Country of Origin
Mexico
Authorized Representative
PT. GE OPERATIONS INDONESIAAR Address
South Quarter Tower B, Lantai 18-19 Jl. R.A. Kartini, Kav. 8 Kel. Cilandak Barat, Kec. Cilandak Jakarta Selataran 12430
Registration Date
Aug 05, 2021
Expiry Date
Feb 28, 2024
Product Type
Diagnostic Cardiology Equipment
Arrhythmia detector and alarm (including ST-segment measurement and alarm).
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