SEA-Clens

No-Rinse Cleanser

Registry build 21.09.26
41manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (11), Zhejiang (9), Hubei (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NEC
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
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Nanjing Anjian Medical Device Co., Ltd. Nanjing Jiangsu Contract manufacturer 22
Tops Medical Articles Industries Nantong Inc Qidong Jiangsu Contract manufacturer 17
Roosin Medical Co., Ltd. Taizhou Jiangsu Contract manufacturer 9
Winner Medical (Jiayu) Co., Ltd. Jiayu Hubei Contract manufacturer 7
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Planet(Shanghai) International Co., Ltd. Shanghai Shanghai Exporter 93
Planet (Anhui) International Co., Ltd. Chuzhou Anhui Exporter 80
Hubei Qianjiang Kingphar Medical Material Co., Ltd. Qianjiang Hubei Contract manufacturer 52

Showing 12 of 41. All 41 manufacturers in China registered for Bandage, Liquid, Skin Protectant

Record

Regulatory record for SEA-Clens
Listed by Coloplast A/S, Denmark
FDA product code NEC
Device type Bandage, Liquid, Skin Protectant
Device class Class 1
Regulation 21 CFR 880.5090
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2022-04-22
Record revised 2024-01-25 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, expiry date
Packaging Shipper box of 12
Sizes Total volume 6 to 12 Fluid Ounce; total volume 178 to 355 ml

Catalogue Numbers

Catalogue numbers for SEA-Clens
Catalogue number Size Status
1061 Total Volume 12 Fluid Ounce In distribution
1063 Total Volume 6 Fluid Ounce In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Coloplast Coloplast A/S 8
Avaline Medical NJ LLC Avaline Medical NJ Limited Liability Company 8
Medline Medline Industries, Inc. 8
Cutimed® BSN Medical, Inc. 6
ProCure Twin Med, LLC 5
Halyard Owens & Minor Distribution, Inc. 4
Brava Coloplast A/S 4
ViveCare Vive Health LLC 3
Aplicare Medline Industries, Inc. 3
Durma+ Unna Boot Bandage with Zinc Oxide Dynarex Corp. 2
Activon Manuka Honey Barrier Cream Brightwake Ltd 2
Adapt Hollister Incorporated 2

Showing 12 of 58. All products under Bandage, Liquid, Skin Protectant

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