Jiangsu Nanfang Medical Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 14 device types, 2 clearances.
Jiangsu Nanfang Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Sling, Arm, Mask, Surgical and 12 other device types. Its earliest product listing with the FDA dates from 2001.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 9710583 |
| FEI number | 3003514271 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No.1 Guoxiang RD. |
| Postal code | 213149 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Nonwoven Mask, Face Mask | 2009 | 439 |
| Bandage, Elastic | Class 1 | Adhesive Retainer, Kinesiology Tape, Acti-Tape, Elastic Bandage | 2006 | 280 |
| Dressing, Wound, Occlusive | Class 1 | Adhesive Dressing | 2006 | 183 |
| First Aid Kit With Drug | Class N | First Aid Kit | 2019 | 57 |
| First Aid Kit Without Drug | Class 1 | First Aid Kit | 2015 | 132 |
| Mask, Surgical | Class 2 | Disposable Medical Mask | 2022 | 125 |
| Medical Glove, Specialty | Class 1 | Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) | 2021 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) | 2021 | 32 |
| Non-Surgical Gown | Class 1 | Protective Gown, Non-surgical Isolation Gown | 2020 | 318 |
| Polymer Patient Examination Glove | Class 1 | Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) | 2021 | 83 |
| Protector, Skin Pressure | Class 1 | Protector, Skin Pressure | 2023 | 101 |
| Respirator, Surgical | Class 2 | KN95 Filtering Facepiece Respirator, KN95 Respirator | 2020 | 118 |
| Sling, Arm | Class 1 | Triangular Bandage | 2016 | 126 |
| Tape And Bandage, Adhesive | Class 1 | Sterilized wound bandage/strips, Sterilized adhesive dressing, Waterproof Tape, Cloth/Silk tape, Transparent/PE tape, Nonwoven/Paper tape and 2 more | 2001 | 353 |
Clearances
2 clearances name Jiangsu Nanfang Medical Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212826 | 2022-01-19 | FXX | Traditional | This company |
| K212639 | 2021-12-08 | LZC | Traditional | This company |
| K210944 | 2021-04-29 | LZA | Traditional | Harbour Health, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | Joint pain relief plasters, Transdermal products, Medical patches |
| OEM and ODM | Offered |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.