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ECTRA II Instrument - Indonesia BPOM Medical Device Registration

ECTRA II Instrument is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20801320678. The device is manufactured by SMITH & NEPHEW, INC., ENDOSCOPY DIVISION (MANSFIELD) from United States, and is classified as Risk Class Kelas Resiko : B. 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 : B
ECTRA II Instrument
Analysis ID: AKL 20801320678

Risk Classification

Kelas Resiko : B

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

Diagnostic Gastroenterology-Urology Equipment

Endoscope and accessories

Non Electromedic Non Sterile

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