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Ophthalmic Optical Coherence Tomography System - Indonesia BPOM Medical Device Registration

Ophthalmic Optical Coherence Tomography System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21201420163. The device is manufactured by GUANGDONG WEIREN MEDITECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PURE SOUTHEAST ASIA 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
Ophthalmic Optical Coherence Tomography System
Analysis ID: AKL 21201420163

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PURE SOUTHEAST ASIA INDONESIA

AR Address

Equity Tower, 26th Floor H, Kav 52-53, Jl. Jenderal Sudirman

Registration Date

Aug 30, 2024

Expiry Date

Apr 24, 2029

Product Type

Diagnostic Eye Equipment

Optical Coherence Tomography

Non Radiation Electromedics

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