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ELVA Swap - Indonesia BPOM Medical Device Registration

ELVA Swap is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20801220414. The device is manufactured by YUWONMEDITECH CO., LTD from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.

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
ELVA Swap

ELVA Trocar

Analysis ID: AKL 20801220414

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Korea

Authorized Representative

PT. ENSEVAL MEDIKA PRIMA

AR Address

JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG

Registration Date

Oct 31, 2022

Expiry Date

Aug 31, 2025

Product Type

Diagnostic Gastroenterology-Urology Equipment

Endoscope and accessories.

Non Electromedic Sterile

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