Eakin
Eakin Freeseal Versa 18mm ostomy barrier seal
33manufacturers in China registered for this device type
11catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (9), Shanghai (3). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Haiyan Kangyuan Medical Instrument Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 17 |
| Zhende Medical Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 14 |
| Zhejiang Ailebao Medical Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 11 |
| Jiangsu Yizheng Carepro Medical Instruments Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 8 |
| Shaoxing Haoshide Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Huida Biopharmaceuticals (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
Showing 12 of 33. All 33 manufacturers in China registered for Protector, Ostomy
Record
| Listed by | T.G. Eakin, Ltd., United Kingdom |
|---|---|
| FDA product code | EXE |
| Device type | Protector, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-02-03 |
| Record revised | 2026-01-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 30 °C |
| Distribution end date | 2026-01-19 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 839027 | 10 | In distribution | |
| 839008 | 10 | In distribution | |
| 839007 | 10 | In distribution | |
| 839028 | 10 | In distribution | |
| 839001 | 10 | Withdrawn | |
| 839002 | 20 | Withdrawn | |
| 839005 | 10 | Withdrawn | |
| 839006 | 10 | Withdrawn | |
| 839010 | Withdrawn | ||
| 839004 | 5 | Withdrawn | |
| 839003 | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AMPatch Stoma Cover | Austin Medical Products, Inc. | 200 |
| SUR-FIT Natura | Convatec, Purchasing Department | 73 |
| Esteem Synergy | Convatec, Purchasing Department | 25 |
| Natura | Convatec, Purchasing Department | 23 |
| Adapt | Hollister Incorporated | 19 |
| Esenta | Convatec, Purchasing Department | 10 |
| CeraPlus | Hollister Incorporated | 9 |
| Adapt CeraRing | Hollister Incorporated | 8 |
| Stomahesive | Convatec, Purchasing Department | 6 |
| ViveCare | Vive Health LLC | 5 |
| Vive | Vive Health LLC | 4 |
| Hollister | Hollister Incorporated | 4 |
Showing 12 of 25. All products under Protector, Ostomy
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| T.G. Eakin, Ltd. | UDI-DI | 2024-08-08 | Class III | Process control | On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005. | 35,400 cartons of 20 individually packaged seals |
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.