Silflex

Soft silicone wound contact layer 12 cm X 15 cm. A wound contact layer made from polyester mesh and coated with Silfix soft silicone. Silflex is designed to gently adhere to the skin…

Registry build 21.09.26

Soft silicone wound contact layer 12 cm X 15 cm. A wound contact layer made from polyester mesh and coated with Silfix soft silicone. Silflex is designed to gently adhere to the skin surrounding a wound and not to the wound bed. This is an atraumatic dressing designed to minimise the pain and trauma associated with dressing change. The dressing’s large perforations allow for the passage of exudate and irrigation of wound.

183manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (54), Jiangsu (41), Guangdong (23). 33 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NAD
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Hubei V-Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 46
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Jinhua Jingdi Medical Supplies Co., Ltd. Jinhua Zhejiang Contract manufacturer 29
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Changzhou Recoo Healthcare Co., Ltd. Changzhou Jiangsu Contract manufacturer 19
Derma Sciences Nantong Incorporation Development Jiangsu Contract manufacturer 19
Henso Medical (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Huizhou Foryou Medical Devices Co., Ltd. Huizhou Guangdong Contract manufacturer 18
Jianerkang Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 18
Anhui Kangfu Industrial Foreign Trade Co., Ltd. Tianchang Anhui Contract manufacturer 18

Showing 12 of 183. All 183 manufacturers in China registered for Dressing, Wound, Occlusive

Record

Regulatory record for Silflex
Listed by Brightwake Ltd, United Kingdom
FDA product code NAD
Device type Dressing, Wound, Occlusive
Device class Class 1
Regulation 21 CFR 878.4020
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2023-07-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Packaging Retail of 10, shipper of 30, shipper of 15, retail of 5, shipper of 18
Sizes Length 7 to 60 cm; width 5 to 35 cm

Catalogue Numbers

Catalogue numbers for Silflex
Catalogue number Size Status
CR3924 Length 15 cm In distribution
CR3922 Length 7 cm In distribution
CR3923 Length 10 cm In distribution
CR3925 Length 30 cm In distribution
CR4006 Length 60 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medline Medline Industries, Inc. 93
MemGard Dalian Orientech Co., Ltd. 89
Leukomed® BSN Medical, Inc. 74
ProCure Twin Med, LLC 62
Cardinal Health Cardinal Health 200, LLC 60
Rhino Rescue Wuxi Emsrun Technology Co., Ltd. 60
Vitale CellEra, LLC 59
McKesson Mckesson Medical-Surgical Inc. 50
ActivHeal Advanced Medical Solutions Ltd 49
3M™ Tegaderm™ 3M Company 44
DeRoyal Deroyal Industries, Inc. 39
Healqu Healqu, LLC 38

Showing 12 of 526. All products under Dressing, Wound, Occlusive

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer