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Medical Device Division · registration 230354Active

Coloplast

Hong KongDressings, Nonimpregnated, Synthetic, SiliconeClass IIIColoplast A/S
Official record identity
MDACS listing number
230354
Model name
Biatain Silicone Non-Border (39022, 39025)
Registration date
October 05, 2023
Expiry date
October 05, 2028
Source update date
February 11, 2025
Status
Active
Official value: Valid
Classification
Risk class
Class III
Official value: III
Published category
Dressings, Nonimpregnated, Synthetic, Silicone
Published parties
Registrant / registration holder
Coloplast (Hong Kong) Limited
Manufacturer
Coloplast A/S
Official description

Scar/Keloid Inhibition Sheets, Silicone

Additional source fields
AMD nomenclature code
21053
Traditional Chinese local responsible person
康樂保(香港)有限公司
Local responsible person phone
36287481
Published manufacturer address
Holtedam1, 3050 Humlebaek, Denmark
About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.