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ORTHO Workstation BioVue - Indonesia BPOM Medical Device Registration

ORTHO Workstation BioVue is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209022159. The device is manufactured by MACK MOLDING COMPANY from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. EMERALINDO ASIA PACIFIC.

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BPOM Registered
Risk Class Kelas Resiko : C
ORTHO Workstation BioVue
Analysis ID: AKL 20209022159

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. EMERALINDO ASIA PACIFIC

AR Address

RUKAN PERMATA SENAYAN BLOK G15, Lantai 1, JL.TENTARA PELAJAR NO. 5, Desa/Kelurahan Grogol Utara, Kec. Kebayoran Lama, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta Kode Pos: 12210

Registration Date

Feb 01, 2024

Expiry Date

Feb 24, 2028

Product Type

Products used in the manufacture of blood preparations and preparations of origin and blood

Automated cell-washing centrifuge for immuno-hematology.

Invitro Diagnostics

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