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AFFINITY Pediatric Arterial Filter - Indonesia BPOM Medical Device Registration

AFFINITY Pediatric Arterial Filter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20504020851. The device is manufactured by MEDTRONIC PERFUSION SYSTEMS from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is MEDTRONIC INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
AFFINITY Pediatric Arterial Filter
Analysis ID: AKL 20504020851

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

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

Oct 09, 2023

Expiry Date

Feb 07, 2028

Product Type

Surgical Cardiology Equipment

Cardiopulmonary prebypass filter.

Non Electromedic Sterile

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