Taiwan FDA registration 0b1a512cfefa58c962734078300126c5
"Besinn" Yukomi waterproof vent fixation device (sterilization)
TW: “拜斯恩” 淥可美防水透氣導管固定裝置(滅菌)
Registration details
- Analysis ID
- 0b1a512cfefa58c962734078300126c5
- Customs Code
- DHA09402269201
Company information
- Manufacturer
- BSN medical GmbH;; BSN MEDICAL GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- UNISON COMPANY LTD.
Product details
- Intended Use
- Limited to the first level recognition range of endovascular catheter fixation device (J.5210) of the classification and grading management method of medical equipment.
- Product Type (Level 1)
- J General hospital and personal use equipment
- Product Type (Level 2)
- J.5210 血管內導管固定裝置
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Nov 04, 2021
- Expiry Date
- Nov 04, 2026
About this record
Access comprehensive regulatory information for "Besinn" Yukomi waterproof vent fixation device (sterilization) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 0b1a512cfefa58c962734078300126c5 and manufactured by BSN medical GmbH;; BSN MEDICAL GMBH. The authorized representative in Taiwan is UNISON COMPANY LTD..
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