Bandex Industrial Corp.
Registered establishment in Zhuhai, Guangdong, China. 14 device types.
Bandex Industrial Corp. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pad, Eye, Pick, Massaging and 12 other device types. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | BANDEX INDUSTRIAL CORP. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007327603 |
| FEI number | 3007327603 |
| Establishment type | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 賓德實業有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Zhuhai |
|---|---|
| Province | Guangdong |
| Address | No.1, Chuangye West Road, Shuanglinpianqu |
| Postal code | 519045 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton applicators | 2023 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Cotton applicators | 2023 | 100 |
| Bandage, Elastic | Class 1 | Bandage, Elastic | 2008 | 280 |
| Dressing, Wound, Occlusive | Class 1 | Dressing, wound, occlusive | 2008 | 183 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face mask per enforcement policy for face masks and respirators during the declared public health emergency | 2020 | 182 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze / sponge,nonresorbable for external use | 2008 | 266 |
| Knife, Orthopedic | Class 1 | Nitrile Gloves, Scissors | 2023 | 7 |
| Medical Glove, Specialty | Class 1 | Nitrile Gloves | 2023 | 48 |
| Pad, Eye | Class 1 | PAD, EYE | 2016 | 100 |
| Pick, Massaging | Class 1 | pick, massaging | 2024 | 46 |
| Polymer Patient Examination Glove | Class 1 | Nitrile Gloves | 2023 | 83 |
| Tape And Bandage, Adhesive | Class 1 | Tape and bandage, adhesive | 2008 | 353 |
| Toothbrush, Manual | Class 1 | Toothbrush, Manual | 2024 | 244 |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | Class 1 | Unit, Ultraviolet Sanitation/Sterilization (FOR Toothbrushes), NON-Sterile | 2024 | 25 |
Clearances
No clearance names Bandex Industrial Corp. as applicant. One 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 |
|---|---|---|---|---|
| K170136 | 2017-08-25 | LZA | Traditional | Shandong Feiyang Professional Gloves Co., Ltd. |
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.