Bioteque
209 catalogue numbers from GH2, listed by Bioteque Taiwan Ltd., Taiwan, under Pessary, Vaginal. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
209catalogue numbers in this listing
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 Taiwan Ltd., Taiwan |
|---|---|
| FDA product code | HHW |
| Device type | Pessary, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3575 |
| Establishment | Contract manufacturer, Contract steriliser, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K092981 |
| Record published | 2024-12-06 |
| Record revised | 2026-06-04 (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 |
|---|---|---|
| GH2 | In distribution | |
| RKs4 | In distribution | |
| OV5 | In distribution | |
| ID5 | In distribution | |
| Rs4 | In distribution | |
| CPs3 | In distribution | |
| GD3 | In distribution | |
| GH0 | In distribution | |
| Ms7 | In distribution | |
| CP2 | In distribution | |
| M4 | In distribution | |
| D4 | In distribution | |
| OVs1 | In distribution | |
| IR4 | In distribution | |
| CUd5 | In distribution | |
| GS4 | In distribution | |
| SH8 | In distribution | |
| RK4 | In distribution | |
| OVs8 | In distribution | |
| SH7 | In distribution | |
| RK6 | In distribution | |
| GS5 | In distribution | |
| CU1 | In distribution | |
| SH1 | In distribution | |
| GS9 | In distribution | |
| HD5 | In distribution | |
| Rs1 | In distribution | |
| Rs5 | In distribution | |
| GD6 | In distribution | |
| CPs7 | In distribution | |
| Ms6 | In distribution | |
| Rs9 | In distribution | |
| RKs3 | In distribution | |
| CU8 | In distribution | |
| RKs1 | In distribution | |
| HDs8 | In distribution | |
| RK0 | In distribution | |
| CUd10 | In distribution | |
| SH6 | In distribution | |
| M8 | In distribution | |
| R2 | In distribution | |
| Ms5 | In distribution | |
| CU0 | In distribution | |
| CU7 | In distribution | |
| CPs6 | In distribution | |
| GS6 | In distribution | |
| OV4 | In distribution | |
| CPs0 | In distribution | |
| GS1 | In distribution | |
| DSHs1 | In distribution | |
| GH3 | In distribution | |
| DSHs2 | In distribution | |
| D2 | In distribution | |
| HDs6 | In distribution | |
| IR6 | In distribution | |
| Ms4 | In distribution | |
| OVs6 | In distribution | |
| OVs7 | In distribution | |
| RK1 | In distribution | |
| SH9 | In distribution | |
| RKs6 | In distribution | |
| ID2 | In distribution | |
| HDs9 | In distribution | |
| DSH5 | In distribution | |
| GH7 | In distribution | |
| IR1 | In distribution | |
| D3 | In distribution | |
| DSHs7 | In distribution | |
| HD7 | In distribution | |
| SH4 | In distribution | |
| CPs2 | In distribution | |
| HD9 | In distribution | |
| D0 | In distribution | |
| Ms2 | In distribution | |
| HDs5 | In distribution | |
| IR3 | In distribution | |
| CUd2 | In distribution | |
| DSHs6 | In distribution | |
| R5 | In distribution | |
| FS10 | In distribution | |
| OVs9 | In distribution | |
| ID4 | In distribution | |
| OV9 | In distribution | |
| OV8 | In distribution | |
| HD2 | In distribution | |
| HD4 | In distribution | |
| R4 | In distribution | |
| Rs2 | In distribution | |
| D1 | In distribution | |
| GH8 | In distribution | |
| OV6 | In distribution | |
| R1 | In distribution | |
| OVs2 | In distribution | |
| CU6 | In distribution | |
| CP4 | In distribution | |
| M6 | In distribution | |
| HD8 | In distribution | |
| GD5 | In distribution | |
| GD1 | In distribution | |
| DSHs5 | In distribution | |
| Rs3 | In distribution | |
| Rs8 | In distribution | |
| GD9 | In distribution | |
| Ms8 | In distribution | |
| CPs4 | In distribution | |
| R6 | In distribution | |
| R7 | In distribution | |
| SH5 | In distribution | |
| R8 | In distribution | |
| HD6 | In distribution | |
| HDs0 | In distribution | |
| CU10 | In distribution | |
| OV2 | In distribution | |
| DSH4 | In distribution | |
| R0 | In distribution | |
| CU2 | In distribution | |
| Rs7 | In distribution | |
| CUd8 | In distribution | |
| FS06 | In distribution | |
| M7 | In distribution | |
| IR5 | In distribution | |
| DSHs0 | In distribution | |
| GS3 | In distribution | |
| CU9 | In distribution | |
| Ms3 | In distribution | |
| CP1 | In distribution | |
| CP0 | In distribution | |
| RK7 | In distribution | |
| OVs5 | In distribution | |
| DSH6 | In distribution | |
| Rs0 | In distribution | |
| OV1 | In distribution | |
| GH5 | In distribution | |
| GH9 | In distribution | |
| CP5 | In distribution | |
| HDs1 | In distribution | |
| GS2 | In distribution | |
| DSH7 | In distribution | |
| GD7 | In distribution | |
| CP6 | In distribution | |
| CP3 | In distribution | |
| D5 | In distribution | |
| IR7 | In distribution | |
| CUd7 | In distribution | |
| FS12 | In distribution | |
| OVs4 | In distribution | |
| CU3 | In distribution | |
| HDs3 | In distribution | |
| RK3 | In distribution | |
| HD1 | In distribution | |
| M2 | In distribution | |
| DSH2 | In distribution | |
| GH4 | In distribution | |
| CUd1 | In distribution | |
| OV3 | In distribution | |
| D7 | In distribution | |
| GH1 | In distribution | |
| CPs1 | In distribution | |
| IR2 | In distribution | |
| DSH1 | In distribution | |
| HDs2 | In distribution | |
| GS8 | In distribution | |
| HD3 | In distribution | |
| SH0 | In distribution | |
| RKs2 | In distribution | |
| RK2 | In distribution | |
| HD0 | In distribution | |
| RK5 | In distribution | |
| CPs5 | In distribution | |
| IR8 | In distribution | |
| CUd9 | In distribution | |
| M3 | In distribution | |
| CUd4 | In distribution | |
| DSH0 | In distribution | |
| GD8 | In distribution | |
| FS08 | In distribution | |
| CUd3 | In distribution | |
| OVs3 | In distribution | |
| RKs5 | In distribution | |
| GS7 | In distribution | |
| DSHs4 | In distribution | |
| RKs0 | In distribution | |
| GD0 | In distribution | |
| HDs7 | In distribution | |
| DSHs3 | In distribution | |
| HDs4 | In distribution | |
| OV7 | In distribution | |
| Rs6 | In distribution | |
| CUd0 | In distribution | |
| GS0 | In distribution | |
| GD10 | In distribution | |
| M5 | In distribution | |
| IR9 | In distribution | |
| CP7 | In distribution | |
| IR0 | In distribution | |
| D6 | In distribution | |
| CUd6 | In distribution | |
| CU5 | In distribution | |
| R3 | In distribution | |
| GD4 | In distribution | |
| RKs7 | In distribution | |
| CU4 | In distribution | |
| ID3 | In distribution | |
| SH3 | In distribution | |
| SH2 | In distribution | |
| DSH3 | In distribution | |
| R9 | In distribution | |
| GD2 | In distribution | |
| GH6 | 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 |
| 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
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.