Vietnam MOH registration 2400989ĐKLH/BYT-HTTB

Mobile Neonatal Incubator

VN: Lồng ấp trẻ sơ sinh di động

Vietnam·Risk Class TTBYT Loại C·TI500 Isolette (Transport Incubator 500)·Draeger Medical Systems, Inc.·Registered Jul 21, 2024

Registration details

Analysis ID: 2400989ĐKLH/BYT-HTTB
Submission ID: 18007627/ĐKLH-BYT-TB-CT
Product Type: TI500 Isolette (Transport Incubator 500)
Product Code: MU20505

Company information

Manufacturer: Draeger Medical Systems, Inc.
Manufacturer Country: UNITED STATES
Product Owner: Draeger Medical Systems, Inc.
Authorized Representative: CÔNG TY TNHH DRAEGER VIỆT NAM

Technical details

Intended Use: The mobile neonatal incubator is designed to transport high-risk, premature, low-birth-weight, or critically ill newborns. The mobile neonatal incubator provides a means to control air temperature, oxygen concentration, and relative humidity. The equipment is designed to accommodate patients up to 10 kg (22 lb).

Dates and status

Registration Date: Jul 21, 2024

About this record

Access comprehensive regulatory information for Mobile Neonatal Incubator in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400989ĐKLH/BYT-HTTB and manufactured by Draeger Medical Systems, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH DRAEGER VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.