Stradis Medical, LCC.
Dressing Change Kit With Biopatch
12manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Hubei (2), Fujian (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Anji Hongde Medical Products Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 47 |
| Bestreat Safety & First AID Solution Co., Ltd. | Wuhan | Hubei | Manufacturer | 35 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Anji Fang Yuan Sanitary Material Co., Ltd. | Anji | Zhejiang | Repacker / relabeller | 13 |
| Shandong Succare Medical Co., Ltd. | Zibo | Shandong | Manufacturer | 12 |
| Ayida (Xiamen) P&C Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 8 |
Record
| Listed by | Stradis Healthcare, United States |
|---|---|
| FDA product code | MCY |
| Device type | Wound Dressing Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5075 |
| Record published | 2017-12-14 |
| Record revised | 2023-02-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Outer box of 20, outer box of 30 |
| Distribution end date | 2023-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IM1229 | In distribution | |
| IM1227 | Withdrawn | |
| IM1263 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 1,221 |
| Medline | Medline Industries, Inc. | 184 |
| Stradis Medical, LLC. | Stradis Healthcare | 116 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 24 |
| Centurion | Centurion Medical Products Corporation | 24 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 15 |
| Wound CareKit | Mirodx, LLC | 12 |
| LSL Healthcare | Lsl Industries, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 11 |
| carePAC | Extremity Care | 11 |
| Medical Action Industries | Medical Action Industries, Inc. | 8 |
| Curaplex | Bound Tree Medical, LLC | 8 |
Showing 12 of 25. All products under Wound Dressing Kit
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.