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STANDARD M10 DENV 1-4 - Indonesia BPOM Medical Device Registration

STANDARD M10 DENV 1-4 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303520109. The device is manufactured by SD BIOSENSOR from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. STANDARD BIOSENSOR INDONESIA.

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
STANDARD M10 DENV 1-4
Analysis ID: AKL 20303520109

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

SD BIOSENSOR

Country of Origin

Korea

Authorized Representative

PT. STANDARD BIOSENSOR INDONESIA

AR Address

L'AVENUE BUILDING UNIT C, LT. 21, JL. RAYA PASAR MINGGU KAV. 16

Registration Date

Feb 10, 2025

Expiry Date

Jan 18, 2029

Product Type

Serological Reagents

Dengue virus nucleic acid amplification test reagents

Invitro Diagnostics

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