Pure Global

ONEHEALTH Film Viewer Lamp - Indonesia BPOM Medical Device Registration

ONEHEALTH Film Viewer Lamp is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11501520006. The device is manufactured by NANCHANG MICARE MEDICAL EQUIPMENT CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. MEDICAL ERA 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : A
ONEHEALTH Film Viewer Lamp
Analysis ID: AKL 11501520006

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

China

Authorized Representative

PT. MEDICAL ERA ALKESINDO

AR Address

Jl. Sisingamangaraja Kilometer 10.8, Komplek Amplas Trade Centre Blok Mahoni nomor 08, Kota Medan, Provinsi Sumatera Utara, Kode Pos: 20148

Registration Date

Jan 08, 2025

Expiry Date

Jan 03, 2028

Product Type

Diagnostic Radiology Equipment

Radiographic film illuminator.

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing