Taiwan FDA registration 53f46b0020071476ef076d1efcf504aa

“gke” Mini-Bio-Plus Self Contained Biological Indicator (Steam)

TW: “記錄易”自含式蒸氣生物指示劑
Taiwan flagTaiwan·Risk Class 2·MD·GKE-GMBH·Registered Aug 04, 2016 – Aug 04, 2026Active
Registration details
Analysis ID
53f46b0020071476ef076d1efcf504aa
License Form
Ministry of Health Medical Device Import No. 028716
Customs Code
DHA05602871609
Company information
Manufacturer
GKE-GMBH
Manufacturer Country
Germany
Authorized Representative
Yida Industrial Co., Ltd
Product details
Intended Use
For details, it is Chinese approved copy of the imitation order
Product Type (Level 1)
J General hospital and personal use equipment
Product Type (Level 2)
J2800 Sterilization Process Indicator
Import Information
Imported from abroad
Dates and status
Registration Date
Aug 04, 2016
Expiry Date
Aug 04, 2026
About this record

Access comprehensive regulatory information for “gke” Mini-Bio-Plus Self Contained Biological Indicator (Steam) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 53f46b0020071476ef076d1efcf504aa and manufactured by GKE-GMBH. The authorized representative in Taiwan is Yida Industrial Co., Ltd.

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