FORTIFY Assura VR - Indonesia BPOM Medical Device Registration
FORTIFY Assura VR is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503918789. The device is manufactured by ABBOTT MEDICAL from Puerto Rico USA, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. TAWADA HEALTHCARE.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
ABBOTT MEDICALCountry of Origin
Puerto Rico USA
Authorized Representative
PT. TAWADA HEALTHCAREAR Address
Rukan Permata Senayan Blok A18-19 Lantai 1-2 Jl. Tentara Pelajar No. 5
Registration Date
Feb 22, 2023
Expiry Date
Oct 11, 2026
Product Type
Prosthetic Cardiology Equipment
Implantable Cardioverter Defibrillator (Non-Crt)
Non Radiation Electromedics
HEARTMATE 3 Left Ventricular Assist System (LVAS)
QUARTETโข Left Heart Lead
QUICKFLEXโข ยต Left Heart Lead
TACTIFLEX โข Sensor Enabled โข Ablation Catheter
ISOFLEX Lead
TACTICATHโข Contact Force Ablation Catheter, Sensor Enabledโข
TactiSys โข Quartz Equipment
ELLIPSEโข VR Implantable Cardioverter Defibrillator
TENDRIL STS Pacing Leads
ELLIPSEโข DR Implantable Cardioverter Defibrillator
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.

