Spatz3 Adjustable Balloon System - Indonesia BPOM Medical Device Registration
Spatz3 Adjustable Balloon System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30805320917. The device is manufactured by SPARROW FGIA, INC from Israel, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. AIR THEN PHARMA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
SPARROW FGIA, INCCountry of Origin
Israel
Authorized Representative
PT. AIR THEN PHARMAAR Address
CITRA TOWER, NORTH TOWER LT 10 UNIT 10 A, JL. BENYAMIN SUAEB KAV. A6, KEMAYORAN, JAKARTA PUSAT 10630
Registration Date
Sep 21, 2023
Expiry Date
Jun 07, 2025
Product Type
Therapeutic Gastroenterology-Urology Equipment
Intragastric Balloon System
Non Electromedic Sterile
HANAROSTENTยฎ Biliary (NC) / BPD
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HANAROSTENT TwynLay โข Colon Rectum (NCN) / TLC
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HANAROSTENTยฎ Duodenum / Pylorus Lasso (NNN) / NDSL
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HANAROSTENT Biliary (NCN) BPA
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HANAROSTENT Colon / Rectum Lasso (NNN) CNZ
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HANAROSTENT Biliary Stent (NNN) BNA
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CHOOSTENT Esophagus (NCN) / EPE
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HANAROSTENT Plumber Biliary (CCC) / BCF
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HANAROSTENT Benefit โข Biliary (NNN) BNHS
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HANAROSTENTยฎ Trachea / Bronchium (NNN) / TNS
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