Pilling
Forbes Esophageal Speculum Adult
9manufacturers in China registered for this device type
94catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Taizhou Honod Medical Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | EPY |
| Device type | Speculum, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2026-07-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Length 30 to 140 mm; length 5.125 to 8.75 in; length 3.3 to 3.5 cm; width 3.3 cm; depth 6.6 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN021690 | In distribution | |
| IPN002102 | Length 5.125 in | In distribution |
| IPN021234 | In distribution | |
| IPN021694 | In distribution | |
| IPN008653 | Length 8.75 in | In distribution |
| IPN021230 | In distribution | |
| IPN021235 | In distribution | |
| IPN021220 | In distribution | |
| IPN021702 | In distribution | |
| IPN021692 | In distribution | |
| IPN021691 | In distribution | |
| IPN928896 | In distribution | |
| IPN021224 | In distribution | |
| IPN056080 | In distribution | |
| IPN021246 | In distribution | |
| IPN021242 | In distribution | |
| IPN021212 | In distribution | |
| IPN021221 | In distribution | |
| IPN006871 | Length 134 mm | In distribution |
| IPN021705 | In distribution | |
| IPN002070 | Length 43 mm | In distribution |
| IPN021222 | In distribution | |
| IPN021211 | In distribution | |
| IPN021709 | In distribution | |
| IPN021217 | In distribution | |
| IPN006875 | Length 140 mm | In distribution |
| IPN008652 | Length 6.375 in | In distribution |
| IPN021695 | In distribution | |
| IPN021229 | In distribution | |
| IPN021232 | In distribution | |
| IPN021706 | In distribution | |
| IPN021244 | In distribution | |
| IPN021701 | In distribution | |
| IPN021697 | In distribution | |
| IPN002056 | Length 3.5 cm | In distribution |
| IPN002103 | Length 5.125 in | In distribution |
| IPN006873 | Length 136 mm | In distribution |
| IPN021688 | In distribution | |
| IPN021202 | In distribution | |
| IPN912030 | In distribution | |
| IPN056079 | In distribution | |
| IPN021199 | In distribution | |
| IPN021201 | In distribution | |
| IPN002099 | Length 6 in | In distribution |
| IPN002057 | Length 30 mm | In distribution |
| IPN002066 | Length 43 mm | In distribution |
| IPN021687 | In distribution | |
| IPN021696 | In distribution | |
| IPN907139 | In distribution | |
| IPN021708 | In distribution | |
| IPN912027 | In distribution | |
| IPN002069 | Length 43 mm | In distribution |
| IPN002726 | In distribution | |
| IPN056081 | In distribution | |
| IPN021227 | In distribution | |
| IPN008653 | Length 8.75 in | In distribution |
| IPN002059 | Length 34 mm | In distribution |
| IPN928895 | In distribution | |
| IPN021704 | In distribution | |
| IPN006872 | Length 137 mm | In distribution |
| IPN021689 | In distribution | |
| IPN021203 | In distribution | |
| IPN021698 | In distribution | |
| IPN002101 | Length 5.125 in | In distribution |
| IPN002098 | Length 5.5 in | In distribution |
| IPN021216 | In distribution | |
| IPN021228 | In distribution | |
| IPN002063 | Length 43 mm | In distribution |
| IPN021717 | In distribution | |
| IPN002064 | Length 43 mm | In distribution |
| IPN002062 | Length 43 mm | In distribution |
| IPN021241 | In distribution | |
| IPN021707 | In distribution | |
| IPN002068 | Length 43 mm | In distribution |
| IPN002730 | In distribution | |
| IPN002092 | Length 5.625 in | In distribution |
| IPN021315 | In distribution | |
| IPN021237 | In distribution | |
| IPN006640 | Length 33 mm | In distribution |
| IPN006639 | Length 3.3 cm | In distribution |
| IPN021699 | In distribution | |
| IPN021243 | In distribution | |
| IPN021240 | In distribution | |
| IPN021231 | In distribution | |
| IPN021213 | In distribution | |
| IPN002100 | Length 5.125 in | In distribution |
| IPN021236 | In distribution | |
| IPN002060 | Length 35 mm | In distribution |
| IPN002065 | Length 43 mm | In distribution |
| IPN021223 | In distribution | |
| IPN021703 | In distribution | |
| IPN008652 | Length 6.375 in | In distribution |
| IPN002058 | Length 32 mm | In distribution |
| IPN002067 | Length 43 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 203 |
| Ambler Surgical | Ambler Surgical, LLC | 190 |
| Sklar® | Sklar Corporation | 180 |
| Aesculap | Aesculap AG | 170 |
| Boss Instruments | Boss Instruments, Ltd. | 161 |
| Fentex | Fentex medical GmbH | 157 |
| Millennium | Avalign Technologies, Inc. | 148 |
| Bear | Bear-ENT, LLC | 145 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 142 |
| BR Surgical, LLC | BR Surgical LLC | 133 |
| Surtex | Surtex Instruments Ltd | 110 |
| Jedmed | Jedmed Instrument Company | 106 |
Showing 12 of 260. All products under Speculum, Ent
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.