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B-ONE Total Hip Instruments - Indonesia BPOM Medical Device Registration

B-ONE Total Hip Instruments is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11303127109. The device is manufactured by B-ONE ORTHO, CORP. from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. KALMED SEJAHTERA INDONESIA.

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 : A
B-ONE Total Hip Instruments
Analysis ID: AKL 11303127109

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Manufacturer

B-ONE ORTHO, CORP.

Country of Origin

United States

Authorized Representative

PT. KALMED SEJAHTERA INDONESIA

AR Address

Jl. TMII Pintu II No. 2, RT 006 RW 004,

Registration Date

Nov 19, 2021

Expiry Date

Aug 06, 2026

Product Type

Surgical Orthopaedic Equipment

Orthopedic manual surgical instrument.

Non Electromedic Non Sterile

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