Incubator for premature babies - Vietnam Registration 2402834ĐKLH/BYT-HTTB

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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2402834ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2402834ĐKLH/BYT-HTTB

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Device Details

Incubator for premature babies

VN: Lồng ấp trẻ sơ sinh

Risk Class TTBYT Loại C

Registration Details

Analysis ID

2402834ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-230310-0018

Product Type

Babyleo TN500

Product Code

2M60000

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.