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SPINEWAY Spinal System Instrumentation - Indonesia BPOM Medical Device Registration

SPINEWAY Spinal System Instrumentation is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11303120988. The device is manufactured by SPINEWAY Ltd. from France, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. ORIONTAMA JAYA.

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
SPINEWAY Spinal System Instrumentation
Analysis ID: AKL 11303120988

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Manufacturer

SPINEWAY Ltd.

Country of Origin

France

Authorized Representative

PT. ORIONTAMA JAYA

AR Address

Jl. Sutomo No. 122-124, Medan

Registration Date

Feb 15, 2021

Expiry Date

Dec 14, 2025

Product Type

Surgical Orthopaedic Equipment

Orthopedic manual surgical instrument.

Non Electromedic Non Sterile

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