Sion Biotext Medical Ltd.
Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical adhesive products.
7manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Shanghai (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| Jinhua Jingdi Medical Supplies Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 29 |
| Zhejiang Excellent United Medical Technology Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 24 |
| Zhejiang Banghaoning Medical Supplies Co., Ltd. | Yiwu | Zhejiang | Manufacturer | 19 |
| Ningbo Greatcare Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 10 |
Record
| Listed by | Sion Biotext Medical Ltd, Israel |
|---|---|
| FDA product code | KOY |
| Device type | Degreaser, Skin, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4730 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1 | 100 | In distribution | |
| 1 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Adhesive Tape Remover Pads | Sion Brands LLC | 2 |
| SafePrep | Spes Medica Srl | 1 |
| PDI® Electrode Prep Pad | Professional Disposables International, Inc. | 1 |
| Electrode Skin Prep Pads | Dynarex Corp. | 1 |
| Tech Stick | Spes Medica Srl | 1 |
| Adhesive Tape Remover Pads, For Professional and Hospital Use | Dynarex Corp. | 1 |
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.