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ELLIPSE VR Implantable Cardioverter Defibrillator - Indonesia BPOM Medical Device Registration

ELLIPSE VR Implantable Cardioverter Defibrillator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503814838. 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 PT. TAWADA HEALTHCARE.

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BPOM Registered
Risk Class Kelas Resiko : D
ELLIPSE VR Implantable Cardioverter Defibrillator
Analysis ID: AKL 30503814838

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Malaysia

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

Rukan Permata Senayan Blok A18-19 Lantai 5 Jl. Tentara Pelajar No. 5

Registration Date

Oct 10, 2024

Expiry Date

Sep 16, 2029

Product Type

Prosthetic Cardiology Equipment

Automatic Implantable Cardioverter Defibrillator With Cardiac Resynchronization (Crt-D)

Non Radiation Electromedics

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