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SPIKE LC N - Indonesia BPOM Medical Device Registration

SPIKE LC N is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20503120519. The device is manufactured by FIAB S.P.A from Italy, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BISAWI GROWS IN HARMONY.

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BPOM Registered
Risk Class Kelas Resiko : B
SPIKE LC N
Analysis ID: AKL 20503120519

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

FIAB S.P.A

Country of Origin

Italy

Authorized Representative

PT. BISAWI GROWS IN HARMONY

AR Address

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

Registration Date

Jun 21, 2022

Expiry Date

Dec 31, 2025

Product Type

Prosthetic Cardiology Equipment

Cardiovascular temporary pacemaker electrode.

Non Electromedic Sterile

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