Taiwan FDA registration 5cf6c68a052338b6f0260c48ab53dede
“TEDAN”Cardiovascular surgical instruments (Non-Sterile)
TW: “帝丹”心臟血管外科器械 (未滅菌)
Taiwan·Risk Class 1·MD·TEDAN SURGICAL INNOVATIONS, LLC·Registered Jul 22, 2020 – Jul 22, 2025ExpiredRegistration details
- Analysis ID
- 5cf6c68a052338b6f0260c48ab53dede
- License Form
- Ministry of Health Medical Device Import No. 021770
- Customs Code
- DHA09402177000
Company information
- Manufacturer
- TEDAN SURGICAL INNOVATIONS, LLC
- Manufacturer Country
- United States
- Authorized Representative
- ASIA HEALTH CARE CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of medical equipment management measures for cardiovascular surgical instruments (E.4500).
- Product Type (Level 1)
- E Cardiovascular devices
- Product Type (Level 2)
- E4500 Cardiovascular Surgical Instrument
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 22, 2020
- Expiry Date
- Jul 22, 2025
About this record
Access comprehensive regulatory information for “TEDAN”Cardiovascular surgical instruments (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5cf6c68a052338b6f0260c48ab53dede and manufactured by TEDAN SURGICAL INNOVATIONS, LLC. The authorized representative in Taiwan is ASIA HEALTH CARE CO., LTD..
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