Taiwan FDA registration 688dd49179bf4941659f9ed6c79d2c7b
"Le Pulse" biological patch
TW: “樂脈”生物性補片
Taiwan·Risk Class 2·LEMAITRE VASCULAR, INC.·Registered Nov 16, 2021 – Nov 16, 2026ActiveRegistration details
- Analysis ID
- 688dd49179bf4941659f9ed6c79d2c7b
- Customs Code
- DHA05603503209
Company information
- Manufacturer
- LEMAITRE VASCULAR, INC.
- Manufacturer Country
- United States
- Authorized Representative
- HSIN TUNG MEDICAL CO., LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- K Neuroscience;;I General, Plastic Surgery and Dermatology; E Cardiovascular Medicine Science
- Product Type (Level 2)
- K.5910 Dural replacement;; I.3300 Surgical Tablets;; E.3470 Heart refill tablets or swabs made of polypropylene, polyethylene, terephthalic acid, etc
- Import Information
- import
Dates and status
- Registration Date
- Nov 16, 2021
- Expiry Date
- Nov 16, 2026
About this record
Access comprehensive regulatory information for "Le Pulse" biological patch in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 688dd49179bf4941659f9ed6c79d2c7b and manufactured by LEMAITRE VASCULAR, INC.. The authorized representative in Taiwan is HSIN TUNG MEDICAL CO., LTD..
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