Helios 500 (Intraoral Scanner) - Indonesia BPOM Medical Device Registration
Helios 500 (Intraoral Scanner) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602420222. The device is manufactured by CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. REVO MEDIKA PARAHYANGAN.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. REVO MEDIKA PARAHYANGANAR Address
Jl. Batununggal Indah II Ruko Blok RD 17 RT.01/RW.05, Desa/Kelurahan Mengger, Kec. Bandung Kidul, Kota Bandung, Provinsi Jawa Barat, Kode Pos: 40267
Registration Date
May 29, 2024
Expiry Date
Feb 02, 2029
Product Type
Prosthetic Dental Equipment
Optical Impression Systems for CAD/CAM.
Non Radiation Electromedics
EIGHTEETH Intraoral Digital Imaging Sensor
UltraMint
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BRILLIANCE Surgical Binocular Loupes and Accessories
SIFARY Dental Curing Light
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Fast-Pack pro
EIGHTEETH E-PEX (Apex Locator)
ENDO MOTOR E-Connect System and Accessories
COLTENE Hyflex EDM files
COLTÈNE/WHALEDENT GMBH + CO. KG.
AVALON BIOMED NeoSEALER Flo
NUSMILE LTD.
SANCTUARY Latex Dental Dam
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ESTELITE POSTERIOR Resin-Based Dental Restorative Material
TOKUYAMA DENTAL CORPORATION KASHIMA FACTORY.
HI-REM Endodontic Post
OVERFIBERS SRL
EIGHTEETH Intraoral Digital Imaging Sensor
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DIATECH Diamond Instruments (System Kit and Refill)
COLTENE/WHALEDENT AG
Dental Alginate Impression Material ( Green Air 454g )
SHAANXI JINGDIAN DENTAL EQUIPMENT CO., LTD
Avalon Biomed NeoMTA 2
NUSMILE LTD.
ESTECEM Plus KIT UNIVERSAL
TOKUYAMA DENTAL CORPORATION KASHIMA FACTORY