Pure Global

DGH Scanmate Flex Ultrasound System - Indonesia BPOM Medical Device Registration

DGH Scanmate Flex Ultrasound System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501814196. The device is manufactured by DGH TECHNOLOGY, INC from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. TRIUMPHANT MANDARIN OPTO-MEDIC.

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 : B
DGH Scanmate Flex Ultrasound System
Analysis ID: AKL 21501814196

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. TRIUMPHANT MANDARIN OPTO-MEDIC

AR Address

Jl. Senen Raya No. 135 Ruko Atrium Blok C No. 15 Jakarta Pusat 10410 Tlp : 021-3515478, 3516018 Fax : 021-3511606

Registration Date

Dec 09, 2022

Expiry Date

Oct 25, 2027

Product Type

Diagnostic Radiology Equipment

Ultrasonic pulsed echo imaging system.

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing