Incubator for premature babies
- Analysis ID
- 2402834ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230310-0018
- Product Type
- Babyleo TN500
- Product Code
- 2M60000
- Manufacturer
- Drägerwerk AG & Co. KGaA
- Manufacturer Country
- GERMANY
- Product Owner
- Dräger
- Authorized Representative
- CÔNG TY TNHH DRAEGER VIỆT NAM
- 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.
- Registration Date
- Oct 22, 2024
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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.
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