AGFA Drystar AXYS Imager - Indonesia BPOM Medical Device Registration
AGFA Drystar AXYS Imager is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501910576. The device is manufactured by AGFA (WUXI) IMAGING CO.,LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is GEVAERT AGFA HEALTHCARE INDONESIA.
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
AGFA (WUXI) IMAGING CO.,LTDCountry of Origin
China
Authorized Representative
GEVAERT AGFA HEALTHCARE INDONESIAAR Address
Jl. Kesehatan Raya No. 23 C RT 010 RW 011
Registration Date
Oct 30, 2023
Expiry Date
Dec 31, 2027
Product Type
Diagnostic Radiology Equipment
Medical image hardcopy device.
Non Radiation Electromedics
AGFA CR 12-X DIGITIZER
AGFA (WUXI) IMAGING CO., LTD
AGFA Flat Panel Detector XD+ 14 (FXRD-3643VAWPLUS)
VIEWORKS CO., LTD.
AGFA Flat Panel Detector XD 14 (FXRD-3643VAW)
VIEWORKS CO., LTD.
AGFA Hardcopy Imager System Drystar 5302
AGFA ( WUXI ) IMAGING CO., LTD.
AGFA ORTHO CP-GU M Medical X-Ray Film
AGFA N.V.
AGFA CR 10-X
AGFA (WUXI) IMAGING CO., LTD.
AGFA Hardcopy Imager System Drystar
AGFA-GEVAERT HEALTHCARE GMBH.

