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COMBITROL Plus B Level 1 - Indonesia BPOM Medical Device Registration

COMBITROL Plus B Level 1 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101914918. The device is manufactured by BIONOSTICS INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ROCHE 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 : B
COMBITROL Plus B Level 1
Analysis ID: AKL 20101914918

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIONOSTICS INC.

Country of Origin

United States

Authorized Representative

PT. ROCHE INDONESIA

AR Address

Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi

Registration Date

Oct 25, 2023

Expiry Date

Sep 26, 2028

Product Type

Clinical Chemistry Test System

Quality control material (assayed and unassayed) (cair)

Invitro Diagnostics

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