CARESTREAM Lux 35 Detector - Indonesia BPOM Medical Device Registration
CARESTREAM Lux 35 Detector is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501220236. The device is manufactured by CARESTREAM HEALTH INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. TAWADA HEALTHCARE.
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
CARESTREAM HEALTH INC.Country of Origin
United States
Authorized Representative
PT. TAWADA HEALTHCAREAR Address
Rukan Permata Senayan Blok A18-19 Lantai 5 Jl. Tentara Pelajar No. 5
Registration Date
Mar 28, 2024
Expiry Date
Jun 30, 2026
Product Type
Diagnostic Radiology Equipment
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Non Radiation Electromedics
QUANTUM 2 (RF 12000)
SMITH & NEPHEW INC, ENDOSCOPY DIVISION
QUARTETโข Left Heart Lead
ABBOTT MEDICAL
ISOFLEX Lead
ABBOTT MEDICAL
SMITH & NEPHEW Fast Fix Instruments
ARTHROCARE CORPORATION
TWINFIX Ti Suture Anchors
ARTHROCARE CORPORATION
QUICKFLEXโข ยต Left Heart Lead
ABBOTT MEDICAL
HAETMED Small Steam Sterilizer
HAETMED (WUXI) CO., LTD.
SMITH & NEPHEW Genesis II Instrument
STRAITS ORTHOPAEDICS (MFG) SDN., BHD.
HAETMED Small Steam Sterilizer
HAETMED (WUXI) CO., LTD.
HAETMED Small Steam Sterilizer
HAETMED (WUXI) CO., LTD.

