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GAREA Fetal/Maternal Monitor - Indonesia BPOM Medical Device Registration

GAREA Fetal/Maternal Monitor is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21101420026. The device is manufactured by SHENZHEN LUCKCOME TECHNOLOGY INC., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. UBC MEDICAL INDONESIA.

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
GAREA Fetal/Maternal Monitor
Analysis ID: AKL 21101420026

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. UBC MEDICAL INDONESIA

AR Address

Jalan Rawa Gelam V, Blok L Kav. 11-13, Kawasan Industri Pulogadung Jakarta Timur13930

Registration Date

May 21, 2024

Expiry Date

Sep 30, 2026

Product Type

Obstetric and Gynecological Monitoring Equipment

Fetal ultrasonic monitor and accessories.

Non Radiation Electromedics

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