Taiwan FDA registration 3f19f57c6e69c5603058311805ca6e9d

"Koca" water-based bandage burn cover (unsterilized)

TW: "科卡" 水性繃帶燒傷覆蓋材 (未滅菌)

Taiwan·Risk Class 1·KOLD-CARE/ROMAINE·Registered Mar 21, 2006 – Mar 21, 2011Cancelled

Registration details

Analysis ID: 3f19f57c6e69c5603058311805ca6e9d
Customs Code: DHA04400307500

Company information

Manufacturer: KOLD-CARE/ROMAINE
Manufacturer Country: United States
Authorized Representative: FU SHING MEDICAL CO., LTD.

Product details

Intended Use: A liquid bandage is a combination of liquid and semi-liquid or powder and liquid, used to cover skin wounds, or as a material for burn dressings, and is also used as a topical skin preparation protectant. However, it is not suitable for severe burns (third degree), non-stitching cannot replace surgical sutures, or the addition of drugs (e.g. antibiotics), or biological agents (e.g. growth hormone), or materials of animal origin.
Product Type (Level 1): J General hospital and personal use equipment
Product Type (Level 2): J.5090 Liquid bandages
Import Information: import

Dates and status

Registration Date: Mar 21, 2006
Expiry Date: Mar 21, 2011
Cancellation Date: Nov 20, 2012

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Koca" water-based bandage burn cover (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3f19f57c6e69c5603058311805ca6e9d and manufactured by KOLD-CARE/ROMAINE. The authorized representative in Taiwan is FU SHING MEDICAL CO., LTD..

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