APELEM RAFALE BDR 40 - Indonesia BPOM Medical Device Registration
APELEM RAFALE BDR 40 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501123036. The device is manufactured by TECHNIX S.P.A. from Italy, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. GRATIA JAYA MULYA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
TECHNIX S.P.A.Country of Origin
Italy
Authorized Representative
PT. GRATIA JAYA MULYAAR Address
Gading Park View, Jl. Boulevard Timur Raya Blok ZC I No. 10-11, RT.4/RW.11, Kel. Kelapa Gading Timur, Kec. Kelapa Gading, Kota Adm. Jakarta Utara, Provinsi DKI Jakarta, Kode Pos 14250
Registration Date
Jan 22, 2025
Expiry Date
Mar 01, 2027
Product Type
Diagnostic Radiology Equipment
Mobile x-ray system.
Electromedic Radiation
ECONOLITH E3000
MEDISPEC LTD.
RAFALE'S APPEAL
TECHNIX S.P.A.
EPED Dental Implant Navigation and Simulation System and Accessories
EPED INC.
KAVO Uniqa and Accessories
KAVO DENTAL GMBH
TORNADO Dental Burs
NINGBO SINYUAN BUR & TOOL CO., LTD.
VINTAGE PRO
SHOFU INC.
SYAS EPIONE OP850 with Accessories
HEYER MEDICAL CO., LTD.
VINTAGE ZR
SHOFU INC.
ELEC ENGINE Dental Engine for Implant Surgery
MICRO-NX CO., LTD.
VINTAGE ART UNIVERSAL
SHOFU INC.

