PRESVAC AP-48L Platelet Shaker - Indonesia BPOM Medical Device Registration

PRESVAC AP-48L Platelet Shaker is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205412173. The device is manufactured by PRESVAC Ltd. from Argentina, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PRIMA ALKESINDO NUSANTARA.

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BPOM Registered

Risk Class Kelas Resiko : B

PRESVAC AP-48L Platelet Shaker

Analysis ID: AKL 20205412173

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

Country of Origin

Argentina

Authorized Representative

PRIMA ALKESINDO NUSANTARA

AR Address

Jl. Bukit Gading Raya Blok C 12 - C 15 Kel. Kelapa Gading Barat, Kec. Kelapa Gading, Jakarta Utara

Registration Date

Dec 09, 2021

Expiry Date

Nov 01, 2026

Product Type

Automatic and Semi-Automatic Hematology Equipment

Automated platelet aggregation system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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