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ORTHO 0.8% SURGISCREEN - Indonesia BPOM Medical Device Registration

ORTHO 0.8% SURGISCREEN is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209520034. The device is manufactured by ORTHO-CLINICAL DIAGNOSTICS INC., from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. DIASTIKA BIOTEKINDO.

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
ORTHO 0.8% SURGISCREEN
Analysis ID: AKL 20209520034

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. DIASTIKA BIOTEKINDO

AR Address

Rukan Sentra Pemuda Kav.30 - 31 Jalan Pemuda No.61 RT.009 RW.003 Kel. Rawamangun Kec.Pulogadung

Registration Date

Feb 04, 2025

Expiry Date

Mar 04, 2027

Product Type

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

Automated blood grouping and antibody test system.

Invitro Diagnostics

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