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KONTOUR PEEK Skull Repairing Systems ( BONE PLATE ) - Indonesia BPOM Medical Device Registration

KONTOUR PEEK Skull Repairing Systems ( BONE PLATE ) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21003917921. The device is manufactured by KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. REKAMILENIUMINDO SELARAS.

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
KONTOUR PEEK Skull Repairing Systems ( BONE PLATE )
Analysis ID: AKL 21003917921

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. REKAMILENIUMINDO SELARAS

AR Address

Jl. Tomang Raya No. 51B RT 01 RW 05

Registration Date

Mar 03, 2021

Expiry Date

Jan 15, 2025

Product Type

Therapeutic Neurology Equipment

Preformed nonalterable cranioplasty plate.

Non Electromedic Non Sterile

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