Bioteque America, Inc.
INCONTINENCE RING PESSARY, Inflatable Donut, ID2.50 #4
4manufacturers in China registered for this device type
221catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Bioteque America, Inc., United States |
|---|---|
| FDA product code | HHW |
| Device type | Pessary, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3575 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K013289 |
| Record published | 2025-05-29 |
| Record revised | 2025-05-09 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Gd0 | In distribution | |
| OV2 | In distribution | |
| D4 | In distribution | |
| HDs5 | In distribution | |
| HD7 | In distribution | |
| OVs2 | In distribution | |
| Rs8 | In distribution | |
| GH5 | In distribution | |
| Ms3 | In distribution | |
| OVs5 | In distribution | |
| D6 | In distribution | |
| FS3000 | In distribution | |
| Ms2 | In distribution | |
| DSH2 | In distribution | |
| CUd3 | In distribution | |
| FS4000 | In distribution | |
| Ms5 | In distribution | |
| R1 | In distribution | |
| HD2 | In distribution | |
| GH7 | In distribution | |
| HDs9 | In distribution | |
| OVs8 | In distribution | |
| CU8 | In distribution | |
| ID4 | In distribution | |
| CU2 | In distribution | |
| RKs2 | In distribution | |
| CPs3 | In distribution | |
| CUd1 | In distribution | |
| DSHs7 | In distribution | |
| HD0 | In distribution | |
| CU6 | In distribution | |
| CU3 | In distribution | |
| GH9 | In distribution | |
| PRM2 | In distribution | |
| SH7 | In distribution | |
| Gd4 | In distribution | |
| FS7000 | In distribution | |
| D1 | In distribution | |
| OVs9 | In distribution | |
| Rs0 | In distribution | |
| IR4 | In distribution | |
| IR1 | In distribution | |
| CPs2 | In distribution | |
| Gd5 | In distribution | |
| CP4 | In distribution | |
| CU4 | In distribution | |
| GS4 | In distribution | |
| FS5000 | In distribution | |
| DSHs6 | In distribution | |
| HD8 | In distribution | |
| RKs1 | In distribution | |
| SH3 | In distribution | |
| FS9900 | In distribution | |
| RK4 | In distribution | |
| CU0 | In distribution | |
| SH1 | In distribution | |
| HD6 | In distribution | |
| Gd7 | In distribution | |
| HD4 | In distribution | |
| DSH4 | In distribution | |
| HDs6 | In distribution | |
| GH0 | In distribution | |
| M3 | In distribution | |
| R7 | In distribution | |
| RK2 | In distribution | |
| CPs4 | In distribution | |
| HD3 | In distribution | |
| FS10 | In distribution | |
| Gd9 | In distribution | |
| FS1100 | In distribution | |
| FS06 | In distribution | |
| HD1 | In distribution | |
| ID2 | In distribution | |
| R5 | In distribution | |
| CUd6 | In distribution | |
| OV4 | In distribution | |
| CPs1 | In distribution | |
| CP7 | In distribution | |
| R4 | In distribution | |
| R2 | In distribution | |
| RKs0 | In distribution | |
| R8 | In distribution | |
| HDs7 | In distribution | |
| ID3 | In distribution | |
| RK6 | In distribution | |
| M5 | In distribution | |
| CU1 | In distribution | |
| CUd9 | In distribution | |
| Rs2 | In distribution | |
| DSH7 | In distribution | |
| RK0 | In distribution | |
| Ms4 | In distribution | |
| GH3 | In distribution | |
| HD5 | In distribution | |
| Rs1 | In distribution | |
| Gd3 | In distribution | |
| RK5 | In distribution | |
| FS8000 | In distribution | |
| CUd8 | In distribution | |
| DSH5 | In distribution | |
| DSHs2 | In distribution | |
| FS1000 | In distribution | |
| OV7 | In distribution | |
| FS6000 | In distribution | |
| FS2000 | In distribution | |
| IR2 | In distribution | |
| Rs3 | In distribution | |
| GS6 | In distribution | |
| SH6 | In distribution | |
| RK1 | In distribution | |
| DSHs5 | In distribution | |
| GH4 | In distribution | |
| CU7 | In distribution | |
| IR3 | In distribution | |
| D5 | In distribution | |
| RKs3 | In distribution | |
| DSHs4 | In distribution | |
| CU5 | In distribution | |
| OV1 | In distribution | |
| CPs5 | In distribution | |
| GS3 | In distribution | |
| GS8 | In distribution | |
| RKs5 | In distribution | |
| RKs4 | In distribution | |
| Rs9 | In distribution | |
| Gd10 | In distribution | |
| RKs6 | In distribution | |
| CU9 | In distribution | |
| HDs8 | In distribution | |
| IR7 | In distribution | |
| IR6 | In distribution | |
| GS2 | In distribution | |
| HDs1 | In distribution | |
| DSHs1 | In distribution | |
| DSH6 | In distribution | |
| SH0 | In distribution | |
| CUd0 | In distribution | |
| Ms7 | In distribution | |
| GH6 | In distribution | |
| GH2 | In distribution | |
| FS08 | In distribution | |
| CP3 | In distribution | |
| GS0 | In distribution | |
| HD9 | In distribution | |
| SH5 | In distribution | |
| SH9 | In distribution | |
| R3 | In distribution | |
| R9 | In distribution | |
| IR9 | In distribution | |
| CPs6 | In distribution | |
| Rs7 | In distribution | |
| CUd7 | In distribution | |
| OV6 | In distribution | |
| IR8 | In distribution | |
| SH4 | In distribution | |
| SH2 | In distribution | |
| GS1 | In distribution | |
| D7 | In distribution | |
| DSH3 | In distribution | |
| R6 | In distribution | |
| RK3 | In distribution | |
| CUd2 | In distribution | |
| DSH0 | In distribution | |
| Rs5 | In distribution | |
| HDs4 | In distribution | |
| M2 | In distribution | |
| CUd5 | In distribution | |
| IR5 | In distribution | |
| HDs2 | In distribution | |
| GS7 | In distribution | |
| Gd2 | In distribution | |
| IR0 | In distribution | |
| D0 | In distribution | |
| CP6 | In distribution | |
| CUd4 | In distribution | |
| GS5 | In distribution | |
| OVs6 | In distribution | |
| OV5 | In distribution | |
| HDs3 | In distribution | |
| Rs4 | In distribution | |
| GS9 | In distribution | |
| CU10 | In distribution | |
| OV8 | In distribution | |
| CP1 | In distribution | |
| Gd8 | In distribution | |
| FS9000 | In distribution | |
| Gd1 | In distribution | |
| CP0 | In distribution | |
| OVs3 | In distribution | |
| Rs6 | In distribution | |
| FS12 | In distribution | |
| CP5 | In distribution | |
| M7 | In distribution | |
| D3 | In distribution | |
| RKs7 | In distribution | |
| CPs7 | In distribution | |
| GH1 | In distribution | |
| OV3 | In distribution | |
| OVs7 | In distribution | |
| M6 | In distribution | |
| M8 | In distribution | |
| ID5 | In distribution | |
| RK7 | In distribution | |
| Ms6 | In distribution | |
| DSHs0 | In distribution | |
| CP2 | In distribution | |
| CPs0 | In distribution | |
| OVs4 | In distribution | |
| DSH1 | In distribution | |
| CUd10 | In distribution | |
| SH8 | In distribution | |
| GH8 | In distribution | |
| Ms8 | In distribution | |
| Gd6 | In distribution | |
| DSHs3 | In distribution | |
| R0 | In distribution | |
| OVs1 | In distribution | |
| D2 | In distribution | |
| HDs0 | In distribution | |
| M4 | In distribution | |
| OV9 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pessary, Vaginal | Panpac Medical Corporation | 628 |
| Milex | Coopersurgical, Inc. | 592 |
| 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 |
| Sklar® | Sklar Corporation | 37 |
Showing 12 of 180. All products under Pessary, Vaginal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K013289 | 2001-12-27 |
| K920747 | 1994-08-29 |
| K920187 | 1992-10-23 |
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.