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OZOCLONE Anti-D (IgM) Blood Grouping Sera Anti-D (IgM) - Indonesia BPOM Medical Device Registration

OZOCLONE Anti-D (IgM) Blood Grouping Sera Anti-D (IgM) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209024057. The device is manufactured by MEDSOURCE OZONE BIOMEDICALS PVT. LTD from India, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SUMIFIN CITRA ABADI.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : C
OZOCLONE Anti-D (IgM) Blood Grouping Sera Anti-D (IgM)
Analysis ID: AKL 20209024057

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

India

Authorized Representative

PT. SUMIFIN CITRA ABADI

AR Address

Jl. Alam Sutera Boulevard Alam Sutera Town Center (ASTC) Blok 10D No.19, Kel. Pakulonan, Kec. Serpong Utara - Tangerang Selatan 15325

Registration Date

Aug 08, 2024

Expiry Date

May 22, 2029

Product Type

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

Blood group substances of nonhuman origin for in vitro diagnostic use.

Invitro Diagnostics

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