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ONEHEALTH Medical Ultrasound Gel - Indonesia BPOM Medical Device Registration

ONEHEALTH Medical Ultrasound Gel is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20903520055. The device is manufactured by FOSHAN PINGCHUANG MEDICAL TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. 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.

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BPOM Registered
Risk Class Kelas Resiko : B
ONEHEALTH Medical Ultrasound Gel
Analysis ID: AKL 20903520055

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

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 14, 2025

Expiry Date

Jan 13, 2028

Product Type

General Hospital Equipment and Other Individuals

Patient lubricant.

Non Electromedic Non Sterile

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