Vietnam MOH registration 2402834ĐKLH/BYT-HTTB

Incubator for premature babies

VN: Lồng ấp trẻ sơ sinh
Vietnam flagVietnam·Risk Class TTBYT Loại C·Babyleo TN500·Drägerwerk AG & Co. KGaA·Registered Oct 22, 2024
Registration details
Analysis ID
2402834ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-230310-0018
Product Type
Babyleo TN500
Product Code
2M60000
Company information
Manufacturer Country
GERMANY
Product Owner
Dräger
Authorized Representative
CÔNG TY TNHH DRAEGER VIỆT NAM
Technical details
Intended Use
The combination incubator and radiant warmer device optimizes the regulation and stabilization of body temperature in premature infants. It can be used flexibly as an incubator or a radiant warmer. The Babyleo TN500 can keep premature babies warm with humidified, oxygen-enriched air (optional). It is used for premature and low-birth-weight infants in the delivery room, the neonatal intensive care unit, and the operating room, for in-hospital patient transport. The device requires operation by qualified medical personnel who have been trained.
Dates and status
Registration Date
Oct 22, 2024
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About this record

Access comprehensive regulatory information for Incubator for premature babies 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 2402834ĐKLH/BYT-HTTB and manufactured by Drägerwerk AG & Co. KGaA. The authorized representative in Vietnam is CÔNG TY TNHH DRAEGER VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Theo theo phụ lục, Atom Medical Corporation, and 5 recent registrations in the same category. 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.

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