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CONFIRM RX Insertable Cardiac Monitor Model DM3500 - Indonesia BPOM Medical Device Registration

CONFIRM RX Insertable Cardiac Monitor Model DM3500 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20502023028. The device is manufactured by ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. TAWADA HEALTHCARE.

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BPOM Registered
Risk Class Kelas Resiko : B
CONFIRM RX Insertable Cardiac Monitor Model DM3500
Analysis ID: AKL 20502023028

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

Rukan Permata Senayan Blok A18-19 Lantai 1-2 Jl. Tentara Pelajar No. 5

Registration Date

Apr 10, 2022

Expiry Date

Dec 31, 2024

Product Type

Monitoring Cardiology Equipment

Medical magnetic tape recorder.

Non Radiation Electromedics

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