Taiwan FDA registration 3711d5f10f56362ce6b2d26a139f8e08
"LUMARK" Pressure Infusor (Non-Sterile)
TW: “璐瑪”輸液加壓袋 (未滅菌)
Taiwan·Risk Class 1·MD·Luma Enterprises Limited New House Factory·Registered Dec 12, 2019 – Dec 12, 2024ExpiredRegistration details
- Analysis ID
- 3711d5f10f56362ce6b2d26a139f8e08
- License Form
- Ministry of Health Medical Device Manufacturing No. 008076
Company information
- Manufacturer
- Luma Enterprises Limited New House Factory
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- LU MARK ENTERPRISES INC.
Product details
- Intended Use
- Limited to the first level identification range of pressure device for blood transfusion bag (J.5420) of the management method for medical equipment.
- Product Type (Level 1)
- J General hospital and personal use equipment
- Product Type (Level 2)
- J5420 Pressure apparatus for blood transfusion bags
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Dec 12, 2019
- Expiry Date
- Dec 12, 2024
About this record
Access comprehensive regulatory information for "LUMARK" Pressure Infusor (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3711d5f10f56362ce6b2d26a139f8e08 and manufactured by Luma Enterprises Limited New House Factory. The authorized representative in Taiwan is LU MARK ENTERPRISES INC..
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