Taiwan FDA registration 099c77b204ff641bfb86429e182ebcd8

“TEPHA” GalaFLEX Scaffold

TW: “緹丰”瑰麗妃修補片

Taiwan·Risk Class 2·MD·Tepha Inc.·Registered Mar 14, 2023 – Mar 14, 2028Active

Registration details

Analysis ID: 099c77b204ff641bfb86429e182ebcd8
License Form: Ministry of Health Medical Device Import No. 036252
Customs Code: DHA05603625202

Company information

Manufacturer: Tepha Inc.
Manufacturer Country: United States
Authorized Representative: Beleli Biotechnology Co., Ltd

Product details

Intended Use: This product is an accessory to sutures, which acts as a reinforcement and repair of soft tissue weaknesses, and is suitable for breast surgery patients who require additional reinforcement materials to obtain the desired surgical results. This product is used in medically necessary breast surgery, when the existing soft tissue is insufficient to support surgical repair, soft tissue repair and reinforcement, such as breast reduction surgery and secondary breast surgery to correct the condition. This product is also suitable for cosmetic breast surgery.
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I3300 Surgical mesh
Import Information: Imported from abroad

Dates and status

Registration Date: Mar 14, 2023
Expiry Date: Mar 14, 2028

About this record

Access comprehensive regulatory information for “TEPHA” GalaFLEX Scaffold in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 099c77b204ff641bfb86429e182ebcd8 and manufactured by Tepha Inc.. The authorized representative in Taiwan is Beleli Biotechnology Co., Ltd.

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