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JANUS Bipolar - Indonesia BPOM Medical Device Registration

JANUS Bipolar is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302914337. The device is manufactured by GRUPPO BIOIMPIANTI S.R.L from Italy, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. INDO PREMIER ORTHO.

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
JANUS Bipolar
Analysis ID: AKL 21302914337

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Italy

Authorized Representative

PT. INDO PREMIER ORTHO

AR Address

Ruko Komp. Taman Palem Lestari Blok P No. 3 RT/RW : 013/008 Kel. Cengkareng Barat, Kec. Cengkareng Jakbar 11730

Registration Date

Jul 17, 2019

Expiry Date

Feb 11, 2024

Product Type

Prosthetic Orthopedic Equipment

Hip joint metal/polymer constrained cemented or uncemented prosthesis.

Non Electromedic Sterile

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