X-TRAX Stone Extraction Balloon - Indonesia BPOM Medical Device Registration
X-TRAX Stone Extraction Balloon is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805220312. The device is manufactured by MEDI-GLOBE GMBH from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MITRAPRIMA LESTARI.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
MEDI-GLOBE GMBHCountry of Origin
Germany
Authorized Representative
PT. MITRAPRIMA LESTARIAR Address
Rukan Sedayu Square Blok I No. 15, RT/RW 002/012, Kelurahan Cengkareng Barat
Registration Date
Sep 08, 2022
Expiry Date
Jul 06, 2026
Product Type
Therapeutic Gastroenterology-Urology Equipment
Biliary catheter and accessories.
Non Electromedic Sterile
MEDI-GLOBE Lithotripsy System Handle
MEDI-GLOBE Mechanical Lithotriptor and Baskets
MEDI-GLOBE Stone Extraction Basket
ROTACUT Sphincterotome
MEDI-GLOBE Pancreatic Stent Set
MEDI-GLOBE Biliary Stent Set
MEDI-GLOBE Dilation Balloon
MEDI-GLOBE E.R.C.P. Catheter
MEDI-GLOBE Guide Wire
YELLOW STAR Double J Ureteric Stent Set
UROTECH GMBH
TRACOE Comfort Tracheostomy Tube
TRACOE MEDICAL GMBH.
VICTO Artificial Urinary Sphincter and Accessories
PROMEDON S.A.
TRACOE Accessories
TRACOE MEDICAL GMBH.
TRACOE Humid Assist III (Non-sterile)
TRACOE MEDICAL GMBH
ARGUS Adjustable Male Sling System
PROMEDON S.A.
VANTRIS VUR Treatment
PROMEDON S.A.
PROMEDON STEEMA Dual TOT Sling System
PROMEDON S.A.
MEDI-GLOBE Mechanical Lithotriptor and Baskets
MEDI-GLOBE GMBH
HSINER Non-Invasive Continuous Positive Airway Pressure Mask
HSINER CO., LTD.

