Taiwan FDA registration 812595bb4a35e2d13e735fe3709cb632

"Luma" infusion pressurized bag (unsterilized)

TW: “璐瑪” 輸液加壓袋(未滅菌)

Taiwan·Risk Class 1·Luma Enterprises Limited;; Zhongyi Industrial Co., Ltd. new housing factory·Registered Nov 23, 2020 – Nov 23, 2025Expired

Registration details

Analysis ID: 812595bb4a35e2d13e735fe3709cb632

Company information

Manufacturer: Luma Enterprises Limited;; Zhongyi Industrial Co., Ltd. new housing 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 the classification and grading management method for medical equipment "Pressure apparatus for intravenous infusion bags (J.5420)".
Product Type (Level 1): J General hospital and personal use equipment
Product Type (Level 2): J.5420 靜脈輸液袋用壓力器
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Nov 23, 2020
Expiry Date: Nov 23, 2025
Cancellation Date: Jun 06, 2024

About this record

Access comprehensive regulatory information for "Luma" infusion pressurized bag (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 812595bb4a35e2d13e735fe3709cb632 and manufactured by Luma Enterprises Limited;; Zhongyi Industrial Co., Ltd. new housing factory. The authorized representative in Taiwan is LU MARK ENTERPRISES INC..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.