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PENUMBRA SYSTEM 3D Revascularization Device - Indonesia BPOM Medical Device Registration

PENUMBRA SYSTEM 3D Revascularization Device is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501121963. The device is manufactured by PENUMBRA, INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is BISAWI GROWS IN HARMONY.

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Risk Class Kelas Resiko : C
PENUMBRA SYSTEM 3D Revascularization Device
Analysis ID: AKL 20501121963

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

PENUMBRA, INC.

Country of Origin

United States

Authorized Representative

BISAWI GROWS IN HARMONY

AR Address

Graha Kencana Blok EU Jl. Raya Perjuangan No.88 Kebun Jeruk Jakarta Barat

Registration Date

Nov 17, 2023

Expiry Date

Dec 31, 2026

Product Type

Diagnostic Cardiology Equipment

Percutaneous catheter.

Non Electromedic Sterile

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