Dilator, Vaginal
Dilator Conical Tubes ID 4.2mm, OD 5.1mm, WL 170mm
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Yuxiang Silicone & Plastic Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Doppkon Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | HDX |
| Device type | Dilator, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3900 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-09-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A-100-080 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dilator, Vaginal | Panpac Medical Corporation | 13 |
| Intimate Rose | Plus EV Holdings Inc | 11 |
| Bioteque | Bioteque Taiwan Ltd. | 11 |
| Bioteque America, Inc. | Bioteque America, Inc. | 11 |
| Hayden Medical | Hayden Medical Inc | 4 |
| Sklar® | Sklar Corporation | 3 |
| Medline | Medline Industries, Inc. | 3 |
| Milli Vaginal Dilator | Materna Medical | 3 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 3 |
| Orthomed | Ortho-MED, Inc. | 1 |
| Hope&Her Vaginal Dilators | Lujena, Inc. | 1 |
| Assi | Accurate Surgical & Scientific Instruments 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.