Taiwan FDA registration e5dcf6c386bc7ef5049016ad8443b62f
"Rien" scalpel (sterilized)
TW: "日恩"手術刀(滅菌)
Taiwan·Risk Class 1·ZIEN Medical Technologies, Inc.·Registered Oct 03, 2017 – Oct 03, 2022CancelledRegistration details
- Analysis ID
- e5dcf6c386bc7ef5049016ad8443b62f
- Customs Code
- DHA09401838003
Company information
- Manufacturer
- ZIEN Medical Technologies, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- BUTICON INTERNATIONAL CORPORATION
Product details
- Intended Use
- Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Manual Instruments for General Surgery (I.4800)".
- Product Type (Level 1)
- I General, Plastic Surgery and Dermatology
- Product Type (Level 2)
- I.4800 Hand Instruments for General Surgery
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Oct 03, 2017
- Expiry Date
- Oct 03, 2022
- Cancellation Date
- Apr 12, 2024
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Rien" scalpel (sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number e5dcf6c386bc7ef5049016ad8443b62f and manufactured by ZIEN Medical Technologies, Inc.. The authorized representative in Taiwan is BUTICON INTERNATIONAL CORPORATION.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices