Taiwan FDA registration 2491b04dabde3315fb668311c79dc3e3
"Medelix" Streta catheters and accessories
TW: “美德力”史翠塔導管及配件
Registration details
- Analysis ID
- 2491b04dabde3315fb668311c79dc3e3
- Customs Code
- DHA05602938007
Company information
- Manufacturer
- Sequel Special Products d.b.a Nissha Medical Technologies, Biomedical Innovations;; Mederi RF LLC
- Manufacturer Country
- United States
- Authorized Representative
- Huizhong Co., Ltd
Product details
- Intended Use
- This product is paired with MDRF1 Generator (177-5150) for the treatment of gastroesophageal reflux disease.
- Product Type (Level 1)
- I General, Plastic Surgery and Dermatology
- Product Type (Level 2)
- I.4400 Cutting and hemostasis electric knives and accessories thereof
- Import Information
- Contract manufacturing;; input
Dates and status
- Registration Date
- May 05, 2017
- Expiry Date
- May 24, 2027
About this record
Access comprehensive regulatory information for "Medelix" Streta catheters and accessories in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2491b04dabde3315fb668311c79dc3e3 and manufactured by Sequel Special Products d.b.a Nissha Medical Technologies, Biomedical Innovations;; Mederi RF LLC. The authorized representative in Taiwan is Huizhong Co., Ltd.
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