Taiwan FDA registration a5d253b0bed4753bb5d20d5d3df4eb2d
“BIOS” SPLENDOR X laser system
TW: “百歐思”史蘭德雷射系統
Registration details
- Analysis ID
- a5d253b0bed4753bb5d20d5d3df4eb2d
- License Form
- Ministry of Health Medical Device Import No. 034940
- Customs Code
- DHA05603494000
Company information
- Manufacturer
- BIOS S.r.l.
- Manufacturer Country
- Italy
- Authorized Representative
- (Hong Kong) Lumenis Be (HK) Limited, Taiwan Branch
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- I General and plastic surgical devices
- Product Type (Level 2)
- I4810 Lasers for general surgery, plastic surgery and dermatology
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 06, 2021
- Expiry Date
- Sep 06, 2026
About this record
Access comprehensive regulatory information for “BIOS” SPLENDOR X laser system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a5d253b0bed4753bb5d20d5d3df4eb2d and manufactured by BIOS S.r.l.. The authorized representative in Taiwan is (Hong Kong) Lumenis Be (HK) Limited, Taiwan Branch.
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