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ON-X® Conform-X® Aortic Prosthetic Heart Valve – Extended Holder - Indonesia BPOM Medical Device Registration

ON-X® Conform-X® Aortic Prosthetic Heart Valve – Extended Holder is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503320292. The device is manufactured by ON-X LIFE TECHNOLOGIES, INC. from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : D
ON-X® Conform-X® Aortic Prosthetic Heart Valve – Extended Holder
Analysis ID: AKL 30503320292

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

United States

Authorized Representative

PT. ANDAMAN MEDICAL INDONESIA

AR Address

Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma

Registration Date

Dec 04, 2023

Expiry Date

Mar 10, 2028

Product Type

Prosthetic Cardiology Equipment

Replacement heart valve.

Non Electromedic Sterile

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