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ELISIO™-L Synthetic Hollow Fiber Polynephron - Indonesia BPOM Medical Device Registration

ELISIO™-L Synthetic Hollow Fiber Polynephron is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805918602. The device is manufactured by NIPRO CORPORATION ODATE FACTORY from Japan, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MAIN WHEEL BEAM.

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
ELISIO™-L Synthetic Hollow Fiber Polynephron
Analysis ID: AKL 20805918602

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Japan

Authorized Representative

PT. MAIN WHEEL BEAM

AR Address

Perkantoran Duta Merlin Blok C No 58 jalan gajah mada

Registration Date

Sep 23, 2024

Expiry Date

Sep 04, 2029

Product Type

Therapeutic Gastroenterology-Urology Equipment

Hemodialysis system and accessories.

Non Electromedic Sterile

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