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ENDOBUTTON Fixation System - Indonesia BPOM Medical Device Registration

ENDOBUTTON Fixation System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603313308. The device is manufactured by SMITH & NEPHEW INC.. ENDOSCOPY DIVISIONS from United States, and is classified as Risk Class Kelas Resiko : C. 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 : C
ENDOBUTTON Fixation System
Analysis ID: AKL 21603313308

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

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

Registration Date

Sep 27, 2024

Expiry Date

Dec 31, 2027

Product Type

Surgical Equipment

Nonabsorbable poly(ethylene terephthalate) surgical suture.

Non Electromedic Sterile

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