Elekta Leksell GammaPlan - Indonesia BPOM Medical Device Registration
Elekta Leksell GammaPlan is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21502320072. The device is manufactured by ELEKTA INSTRUMENT AB from Sweden, 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
ELEKTA INSTRUMENT ABCountry of Origin
Sweden
Authorized Representative
PT. ELEKTA MEDICAL SOLUTIONSAR Address
Cowell Tower Lt. 7 Unit 02A, Jl. Senen Raya No. 135
Registration Date
Mar 01, 2023
Expiry Date
Nov 24, 2027
Product Type
Therapeutic Radiology Equipment
Radiation therapy simulation system.
Non Radiation Electromedics
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 ProSTEP
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
IT-V BreastSTEP
IT-V MEDIZINTECHNIK GMBH

