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DENSIRON Xtra - Indonesia BPOM Medical Device Registration

DENSIRON Xtra is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31203912026. The device is manufactured by FLUORON GMBH from Germany, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. SURGIKA ALKESINDO.

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 : D
DENSIRON Xtra
Analysis ID: AKL 31203912026

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

FLUORON GMBH

Country of Origin

Germany

Authorized Representative

PT. SURGIKA ALKESINDO

AR Address

Jl. Letjen Suprapto No.60, Gedung Indra Sentral unit G-H, Cempaka Putih

Registration Date

May 30, 2023

Expiry Date

Apr 06, 2026

Product Type

Surgical Eye Equipment

Intraocular fluid.

Non Electromedic Sterile

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