Yoni.Fit Bladder Support
Yoni.Fit Bladder Support Kit Three - Pink: Includes Sizes 4 and 5, Storage Container, Cleaning Brush, and Instructions for Use
4manufacturers in China registered for this device type
11catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| B&A Precision Silicone Rubber (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Guangzhou Fame Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Watkins-Conti Products, Inc, United States |
|---|---|
| FDA product code | HHW |
| Device type | Pessary, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3575 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K232525 |
| Record published | 2024-07-31 |
| Record revised | 2026-04-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 68 to 77 °F; Storage environment temperature 20 to 25 °C |
| Packaging | Pack of 6, case of 6, pack of 8, case of 8 |
| Sizes | Outer diameter 34 to 52 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PT-A-0016 | Outer Diameter 45 mm | In distribution |
| PT-A-0015 | Outer Diameter 34 mm | In distribution |
| PT-A-0013 | Outer Diameter 52 mm | In distribution |
| PT-1005 | Outer Diameter 48 mm | In distribution |
| PT-1002 | Outer Diameter 34 mm | In distribution |
| PT-A-0012 | Outer Diameter 42 mm | In distribution |
| PT-1006 | Outer Diameter 52 mm | In distribution |
| PT-1004 | Outer Diameter 42 mm | In distribution |
| PT-1003 | Outer Diameter 38 mm | In distribution |
| PT-A-0011 | Outer Diameter 34 mm | In distribution |
| PT-1007 | Outer Diameter 45 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pessary, Vaginal | Panpac Medical Corporation | 628 |
| Milex | Coopersurgical, Inc. | 592 |
| Bioteque America, Inc. | Bioteque America, Inc. | 221 |
| Bioteque | Bioteque Taiwan Ltd. | 209 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 189 |
| HNM Women Care | HNM Stainless, LLC. | 187 |
| Medline | Medline Industries, Inc. | 162 |
| Marina Medical | Marina Medical Instruments, Inc. | 144 |
| EvaCare | Personal Medical Corp. | 128 |
| Hayden Medical | Hayden Medical Inc | 81 |
| Premier | Premier Dental Products Co. | 58 |
| LTL Medical | Bioteque Taiwan Ltd. | 56 |
Showing 12 of 180. All products under Pessary, Vaginal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232525 | 2024-05-17 |
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.