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RENMED A.V Fistula Needle Set - Indonesia BPOM Medical Device Registration

RENMED A.V Fistula Needle Set is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805906335. The device is manufactured by SUNDER BIOMEDICAL TECH CO., LTD., PAO-CHUNG HSIANG FACTORY from Taiwan (China), and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.

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 : C
RENMED A.V Fistula Needle Set
Analysis ID: AKL 20805906335

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Taiwan (China)

Authorized Representative

PT. ENSEVAL MEDIKA PRIMA

AR Address

Jl. Pulolentut No. 12 Kawasan Industri Pulogadung

Registration Date

May 22, 2018

Expiry Date

Dec 31, 2023

Product Type

Therapeutic Gastroenterology-Urology Equipment

Blood access device and accessories.

Non Electromedic Sterile

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