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ELLIPSE DR ™ Implantable Cardioverter Defibrillator - Indonesia BPOM Medical Device Registration

ELLIPSE DR ™ Implantable Cardioverter Defibrillator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503918754. 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.

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.

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Risk Class Kelas Resiko : D
ELLIPSE DR ™ Implantable Cardioverter Defibrillator
Analysis ID: AKL 30503918754

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

ABBOTT MEDICAL

Country of Origin

Puerto Rico USA

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

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

Registration Date

Nov 11, 2024

Expiry Date

Apr 08, 2029

Product Type

Prosthetic Cardiology Equipment

Implantable Cardioverter Defibrillator (Non-Crt)

Non Radiation Electromedics

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