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SMITH & NEPHEW Genesis II Instrument - Indonesia BPOM Medical Device Registration

SMITH & NEPHEW Genesis II Instrument is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11303220080. The device is manufactured by STRAITS ORTHOPAEDICS (MFG) SDN., BHD. from Malaysia, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. TAWADA HEALTHCARE.

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
SMITH & NEPHEW Genesis II Instrument
Analysis ID: AKL 11303220080

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

Malaysia

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

Rukan Permata Senayan Blok A18-19 Lantai 5 Jl. Tentara Pelajar No. 5

Registration Date

Feb 03, 2025

Expiry Date

Dec 31, 2027

Product Type

Surgical Orthopaedic Equipment

Orthopedic manual surgical instrument.

Non Electromedic Non Sterile

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