Taiwan FDA registration 5ec4c665fcfc4648845fa7f3c440de97

Bundy gel patch

TW: 邦迪凝膠貼布

Taiwan·Risk Class 1·COLOPLAST A/S·Registered Mar 13, 2006 – Mar 13, 2011Cancelled

Registration details

Analysis ID: 5ec4c665fcfc4648845fa7f3c440de97
Customs Code: DHA04400287004

Company information

Manufacturer: COLOPLAST A/S
Manufacturer Country: Denmark
Authorized Representative: JOHNSON & JOHNSON TAIWAN LTD.

Product details

Intended Use: Sealed wound covering is a non-absorbent sterile or non-sterile device intended to cover the wound, provide or supply a wound environment containing moisture, and enable oxygen and other gases and water vapor to be exchanged through this device, and its composition is a synthetic polymer material such as polyurethane, with or without adhesive straps. Not suitable for severe burns (Grade 3), not a substitute for surgical sutures, no additives (e.g. antibiotics), or biologics (e.g. growth hormone), or materials of animal origin.
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4020 閉合用傷口/燒燙傷敷料
Import Information: import

Dates and status

Registration Date: Mar 13, 2006
Expiry Date: Mar 13, 2011
Cancellation Date: Nov 16, 2012

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for Bundy gel patch in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5ec4c665fcfc4648845fa7f3c440de97 and manufactured by COLOPLAST A/S. The authorized representative in Taiwan is JOHNSON & JOHNSON TAIWAN LTD..

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