Taiwan FDA registration 5adde89190595118053a1fdc8c175070
"Leach" cell matrix Aqipei blood cell isolation group (joint injection)
TW: “利奇”細胞基質艾奇沛血球細胞分離組(關節注射液)
Taiwan·Risk Class 3·REGEN LAB SA·Registered Jun 10, 2019 – Jun 10, 2029ActiveRegistration details
- Analysis ID
- 5adde89190595118053a1fdc8c175070
- Customs Code
- DHA05603271101
Company information
- Manufacturer
- REGEN LAB SA
- Manufacturer Country
- Switzerland
- Authorized Representative
- QUALTECH CONSULTING CORPORATION
Product details
- Intended Use
- This product consists of multiple sterile and pyrogen-free collection tubes and is designed to prepare a mixture of platelet thick solution (PRP) and hyaluronic acid (HA), 3 ml of platelet thick solution (PRP) corresponds to 2 ml of hyaluronic acid (HA). Each box includes 3 A-CP-HA blood collection tubes in individual plastic packaging. For the preparation of intra-articular injections for the treatment of knee pain, such as grade I to III knee osteoarthritis. It is recommended to inject one tube per injection for a total of three injections, each with two weeks apart.
- Product Type (Level 1)
- N 骨科學;; B 血液學、病理學及基因學
- Product Type (Level 2)
- N.0003 Articular filler implants; B.9245 Automated hemocytoseparator
- Import Information
- import
Dates and status
- Registration Date
- Jun 10, 2019
- Expiry Date
- Jun 10, 2029
About this record
Access comprehensive regulatory information for "Leach" cell matrix Aqipei blood cell isolation group (joint injection) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 5adde89190595118053a1fdc8c175070 and manufactured by REGEN LAB SA. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.
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