LUTONIX 018 Drug Coated Balloon PTA Catheter - Indonesia BPOM Medical Device Registration
LUTONIX 018 Drug Coated Balloon PTA Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505127418. The device is manufactured by C.R. BARD from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. ITAMA RANORAYA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
C.R. BARDCountry of Origin
United States
Authorized Representative
PT. ITAMA RANORAYAAR Address
MT Haryono Square Lantai 1 Unit 1, Jl. Otto Iskandardinata Raya No. 390 RT 006 RW 012 Kel. Bidara Cina, Kec. Jatinegara, Jakarta Timur, DKI Jakarta
Registration Date
Dec 01, 2021
Expiry Date
Dec 31, 2025
Product Type
Therapeutic Cardiology Equipment
Drug Eluting Balloon
Non Electromedic Sterile
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