Binx Io
Female collection kit
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Binx Health, Ltd., United Kingdom |
|---|---|
| FDA product code | LIO |
| Device type | Device, Specimen Collection |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2900 |
| Establishment | Manufacturer |
| 510(k) | K200533 |
| Record published | 2025-09-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Foil pouch of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V1 (CT/NG) | In distribution | |
| V1 (CT/NG) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 21 |
| Sigma Virocult | Medical Wire & Equipment Company (Bath), Ltd. | 16 |
| Transwab | Medical Wire & Equipment Company (Bath), Ltd. | 14 |
| Puritan UniTranz-RT | Puritan Medical Products Company LLC | 13 |
| Sigma Transwab | Medical Wire & Equipment Company (Bath), Ltd. | 11 |
| Starswab II Bacteriology Culture Collection and Transport System | Pretium Canada Packaging ULC | 10 |
| Vacuette | Greiner BIO-ONE Gmbh | 4 |
| Bacti-Swab | Remel, Inc. | 4 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Puritan | Puritan Medical Products Company LLC | 4 |
| Covidien | Cardinal Health 200, LLC | 3 |
| Puritan Opti-Swab | Puritan Medical Products Company LLC | 3 |
Showing 12 of 35. All products under Device, Specimen Collection
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.