Taiwan FDA registration 05c0112802fde5672ab3f8bee9ab3ff6

"Hama" Blood Preservation Refrigerator and Freezer (Unsterilized)

TW: "哈瑪" 血液保存之冰箱與冷凍箱 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·HELMER INC.·Registered May 08, 2013 – May 08, 2028Active
Registration details
Analysis ID
05c0112802fde5672ab3f8bee9ab3ff6
Customs Code
DHA04401298909
Company information
Manufacturer
HELMER INC.
Manufacturer Country
United States
Authorized Representative
OMEGA MEDICAL TAIWAN LIMITED
Product details
Intended Use
Limited to the first level identification range of the Measures for the Administration of Medical Devices "Refrigerators and Freezers for Blood Preservation (B9700)".
Product Type (Level 1)
B Hematology, pathology, and genetics
Product Type (Level 2)
B.9700 Refrigerator and freezer for blood preservation
Import Information
import
Dates and status
Registration Date
May 08, 2013
Expiry Date
May 08, 2028
About this record

Access comprehensive regulatory information for "Hama" Blood Preservation Refrigerator and Freezer (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 05c0112802fde5672ab3f8bee9ab3ff6 and manufactured by HELMER INC.. The authorized representative in Taiwan is OMEGA MEDICAL TAIWAN LIMITED.

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