Dragonfly OpStar Imaging Catheter - Indonesia BPOM Medical Device Registration
Dragonfly OpStar Imaging Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501321215. The device is manufactured by ABBOTT MEDICAL from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is 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
ABBOTT MEDICALCountry of Origin
United States
Authorized Representative
TAWADA HEALTHCAREAR Address
Rukan Permata Senayan Blok A18-19 Lantai 1-2 Jl. Tentara Pelajar No. 5
Registration Date
Dec 17, 2023
Expiry Date
Jul 27, 2028
Product Type
Diagnostic Cardiology Equipment
Diagnostic intravascular catheter.
Non Electromedic Sterile
QUICKFLEXโข ยต Left Heart Lead
ISOFLEX Lead
TACTICATHโข Contact Force Ablation Catheter, Sensor Enabledโข
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QUARTETโข Left Heart Lead
HEARTMATE 3 Left Ventricular Assist System (LVAS)
TactiSys โข Quartz Equipment
ELLIPSEโข DR Implantable Cardioverter Defibrillator
TENDRIL STS Pacing Leads
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HaeTmed Small Steam Sterilizer
HAETMED (WUXI) CO., LTD.
SUTUREFIX Suture Anchor
ARTHROCARE CORPORATION
SUTUREFIX Suture Anchor
SMITH & NEPHEW INC. ENDOSCOPY
ULTRATAPE Suture
ARTHROCARE CORPORATION
ULTRABUTTON Adjustable Fixation Device
ARTHROCARE CORPORATION
HUGE Denture Base Polymers
SHANDONG HUGE DENTAL MATERIAL CORPORATION
ALPHALAB Duplication Silicone Material
SHANDONG HUGE DENTAL MATERIAL CORPORATION.
ALPHALAB Duplication Silicone Material
SHANDONG HUGE DENTAL MATERIAL CORPORATION
CORI Instrument
SMITH & NEPHEW INC. ENDOSCOPY
CORI Instrument
STRAITS ORTHOPAEDICS (MFG) SDN BHD

