GALLANT ™ VR Implantable Cardioverter Defibrillators (ICDs) and CRT-Ds - Indonesia BPOM Medical Device Registration
GALLANT ™ VR Implantable Cardioverter Defibrillators (ICDs) and CRT-Ds is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503220067. The device is manufactured by ST. JUDE MEDICAL OPERATIONS (M) SDN BHD from Malaysia, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is TAWADA HEALTHCARE.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
ST. JUDE MEDICAL OPERATIONS (M) SDN BHDCountry of Origin
Malaysia
Authorized Representative
TAWADA HEALTHCAREAR Address
Rukan Permata Senayan Blok A18-19 Lantai 1-2 Jl. Tentara Pelajar No. 5
Registration Date
Jul 22, 2022
Expiry Date
Oct 11, 2026
Product Type
Prosthetic Cardiology Equipment
Automatic Implantable Cardioverter Defibrillator With Cardiac Resynchronization (Crt-D)
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GALLANT™ DR Implantable Cardioverter Defibrillators (ICDs) and CRT-Ds
ENTRANT™ HF Implantable Cardioverter Defibrillators (ICDs) and CRT-Ds
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