Taiwan FDA registration 511d02b3131fc33267fef3e20d562cad
“Medtronic” Guardian 2 Link System Kit
TW: “美敦力” 捍衛者傳輸器系統
Taiwan·Risk Class 2·MD·MEDTRONIC MINIMED·Registered Oct 13, 2017 – Oct 13, 2022ExpiredRegistration details
- Analysis ID
- 511d02b3131fc33267fef3e20d562cad
- License Form
- Ministry of Health Medical Device Import No. 030066
- Customs Code
- DHA05603006601
Company information
- Manufacturer
- MEDTRONIC MINIMED
- Manufacturer Country
- United States
- Authorized Representative
- MEDTRONIC (TAIWAN) LTD.
Product details
- Intended Use
- Suitable for a single patient, this product is part of the Medtronic Continuous Glucose Monitoring System and the sensor-enabled Mini Pumping System that collects data from the Enlite glucose sensor and transmits the data wirelessly to the Insulin Pump.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1345 Glucose Test System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 13, 2017
- Expiry Date
- Oct 13, 2022
About this record
Access comprehensive regulatory information for “Medtronic” Guardian 2 Link System Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 511d02b3131fc33267fef3e20d562cad and manufactured by MEDTRONIC MINIMED. The authorized representative in Taiwan is MEDTRONIC (TAIWAN) LTD..
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