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
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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