URGOK2

URGOK2 is a two layer compression system including KTECH: a white, short-stretch bandage; providing compression, protection and absorbency and KPRESS: a cohesive long-stretch bandage…

Registry build 21.09.26

URGOK2 is a two layer compression system including KTECH: a white, short-stretch bandage; providing compression, protection and absorbency and KPRESS: a cohesive long-stretch bandage providing the additional compression necessary to achieve therapeutic pressure and secure the bandages in place. URGOK2 is for the treatment of venous leg ulcer, venous edema and lymphedema, which require full compression. Not made with natural rubber latex.

280manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (85), Zhejiang (75), Guangdong (29). 38 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FQM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Suzhou Pipi Medical Products Co., Ltd. Suzhou Jiangsu Contract manufacturer 48
Hubei V-Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 46
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Jiangsu Huadong Medical Device Industry Co., Ltd. Yangzhou Jiangsu Contract manufacturer 29
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Nanjing 3H Medical Products Co., Ltd. Nanjing Jiangsu Contract manufacturer 25
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23

Showing 12 of 280. All 280 manufacturers in China registered for Bandage, Elastic

Record

Regulatory record for URGOK2
Listed by Urgo Medical North America, LLC, United States
FDA product code FQM
Device type Bandage, Elastic
Device class Class 1
Regulation 21 CFR 880.5075
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2019-12-26
Record revised 2022-06-10 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Special storage condition: Store away from light and heat.
Packaging Case of 21, case of 27

Catalogue Numbers

Catalogue numbers for URGOK2
Catalogue number Size Status
553243 Width of bandages: 4 inches (10 cm) In distribution
553244 Width of bandages: 4 inches (10 cm) In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeRoyal Deroyal Industries, Inc. 194
MT Spandage Medi-Tech, Inc. 107
Tronex International, Inc. Tronex International, Inc. 79
Bioseal Inc. Bioseal 57
Medline Medline Industries, Inc. 56
3M™ Coban™ 3M Company 52
Sensi-Wrap, Self Adherent Dynarex Corp. 49
Cardinal Health Cardinal Health 200, LLC 49
Bandage, Elastic Tetra Medical Supply Corp. 48
PremierPro Prestige Ameritech 48
Co-Ease Hemasource 45
CotZee Hemasource 44

Showing 12 of 345. All products under Bandage, Elastic

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