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Ensemble II Transcatheter Valve Delivery System - Indonesia BPOM Medical Device Registration

Ensemble II Transcatheter Valve Delivery System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505122339. The device is manufactured by NUMED INC from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is MEDTRONIC INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : D
Ensemble II Transcatheter Valve Delivery System
Analysis ID: AKL 30505122339

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

NUMED INC

Country of Origin

United States

Authorized Representative

MEDTRONIC INDONESIA

AR Address

Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda, Desa/Kelurahan Kebayoran Lama Utara, Kec. Kebayoran Lama

Registration Date

Dec 19, 2023

Expiry Date

Feb 06, 2028

Product Type

Therapeutic Cardiology Equipment

Percutaneous catheter for coronary use

Non Electromedic Sterile

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