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PRIMADO2 Total Surgical System - Indonesia BPOM Medical Device Registration

PRIMADO2 Total Surgical System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21002220013. The device is manufactured by NAKANISHI INC. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. QUALTEK CONSULTANT JAKARTA.

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
PRIMADO2 Total Surgical System
Analysis ID: AKL 21002220013

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

NAKANISHI INC.

Country of Origin

Japan

Authorized Representative

PT. QUALTEK CONSULTANT JAKARTA

AR Address

Icon Business Park Blok K No 6, BSD City, Kab Tangerang, Banten

Registration Date

Apr 01, 2022

Expiry Date

Jan 11, 2027

Product Type

Surgical Neurology Equipment

Powered simple cranial drills, burrs, trephines, and their accessories.

Non Radiation Electromedics

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