IT-V ProSTEP - Indonesia BPOM Medical Device Registration
IT-V ProSTEP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21502320120. The device is manufactured by IT-V MEDIZINTECHNIK GMBH from Austria, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ELEKTA MEDICAL SOLUTIONS.
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
IT-V MEDIZINTECHNIK GMBHCountry of Origin
Austria
Authorized Representative
PT. ELEKTA MEDICAL SOLUTIONSAR Address
Cowell Tower Lantai 7 Unit 02A, Jl. Senen Raya No. 135, Kode Pos 10410, Kel. Senen, Kec. Senen, Kota Jakarta Pusat, Prov. DKI Jakarta
Registration Date
Oct 04, 2023
Expiry Date
Jun 12, 2028
Product Type
Therapeutic Radiology Equipment
Medical charged-particle radiation therapy system.
Non Electromedic Non Sterile
MOSAIQ Oncology Information System
ELEKTA INC.
iBEAM evo CT Overlay
3C-MEDICAL INTELLIGENCE GMBH
ELEKTA Harmony Pro
ELEKTA BEIJING MEDICAL SYSTEMS CO., LTD.
Elekta Harmony
ELEKTA BEIJING MEDICAL SYSTEMS CO., LTD.
IT-V Overlay
IT-V MEDIZINTECHNIK GMBH
IT-V BreastSTEP
IT-V MEDIZINTECHNIK GMBH
HeadSTEP Patient Support
IT-V MEDIZINTECHNIK GMBH
IT-V M STEP Patient Support
IT-V MEDIZINTECHNIK GMBH
IT-V MouthBITE Patient Support
IT-V MEDIZINTECHNIK GMBH
WingSTEP patient support
IT-V MEDIZINTECHNIK GMBH

