HALO ONE ™ Thin-Walled Guiding Sheath - Indonesia BPOM Medical Device Registration
HALO ONE ™ Thin-Walled Guiding Sheath is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501420062. The device is manufactured by CLEARSTREAM TECHNOLOGIES LTD. from Ireland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BECTON DICKINSON INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
CLEARSTREAM TECHNOLOGIES LTD.Country of Origin
Ireland
Authorized Representative
PT. BECTON DICKINSON INDONESIAAR Address
SAMPOERNA STRATEGIC SQUARE, SOUTH TOWER LT.20 JL. JEND SUDIRMAN KAV 45-46
Registration Date
Jan 31, 2024
Expiry Date
Sep 27, 2028
Product Type
Diagnostic Cardiology Equipment
Catheter introducer
Non Electromedic Sterile
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