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ZONDAN Fetal Monitor - Indonesia BPOM Medical Device Registration

ZONDAN Fetal Monitor is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21102013491. The device is manufactured by SHENZHEN HEXIN ZONDAN MEDICAL EQUIPMENT CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MANDIRI JAYA MEDIKA.

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
ZONDAN Fetal Monitor
Analysis ID: AKL 21102013491

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. MANDIRI JAYA MEDIKA

AR Address

Graha Mas Fatmawati B20 JL. RS.Fatmawati No. 71 Cipete Utara - Kebayoran Baru

Registration Date

Apr 16, 2019

Expiry Date

Jan 17, 2024

Product Type

Obstetric and Gynecological Monitoring Equipment

Fetal ultrasonic monitor and accessories.

Non Radiation Electromedics

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