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AFFINITY AF 100 Arterial Filter with Balance Biosurface - Indonesia BPOM Medical Device Registration

AFFINITY AF 100 Arterial Filter with Balance Biosurface is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20504420014. 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 PT. MEDTRONIC INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
AFFINITY AF 100 Arterial Filter with Balance Biosurface
Analysis ID: AKL 20504420014

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. 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

Feb 04, 2024

Expiry Date

Feb 06, 2028

Product Type

Surgical Cardiology Equipment

Cardiopulmonary bypass arterial line blood filter.

Non Electromedic Sterile

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