Pure Global

ANDALAN IUD TCu 380A - Indonesia BPOM Medical Device Registration

ANDALAN IUD TCu 380A is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31104514689. The device is manufactured by PREGNA INTERNATIONAL LTD. from India, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is DKT INTERNATIONAL.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : D
ANDALAN IUD TCu 380A
Analysis ID: AKL 31104514689

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

India

Authorized Representative

DKT INTERNATIONAL

AR Address

GRAHA SUCOFINDO Lantai 12 Jl. Raya Pasar Minggu Kav. 34

Registration Date

Jun 23, 2022

Expiry Date

Feb 01, 2027

Product Type

Therapeutic Obstetric and Gynecological Equipment

Contraceptive intrauterine device (IUD) and introducer.

Non Electromedic Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing