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“TEPHA” GalaFLEX Scaffold - Taiwan Registration 099c77b204ff641bfb86429e182ebcd8

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.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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099c77b204ff641bfb86429e182ebcd8
Registration Details
Taiwan FDA Registration: 099c77b204ff641bfb86429e182ebcd8
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Device Details

“TEPHA” GalaFLEX Scaffold
TW: “緹丰”瑰麗妃修補片
Risk Class 2
MD

Registration Details

099c77b204ff641bfb86429e182ebcd8

Ministry of Health Medical Device Import No. 036252

DHA05603625202

Company Information

United States

Product Details

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.

I General, Plastic Surgery and Dermatology

I3300 Surgical mesh

Imported from abroad

Dates and Status

Mar 14, 2023

Mar 14, 2028