Medicon
Killian nasal speculum 15cm lf serr 35mm rt 55mm w conn
9manufacturers in China registered for this device type
86catalogue 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 | Medicon eG. Chirurgiemechaniker-Genossenschaft |
|---|---|
| FDA product code | EPY |
| Device type | Speculum, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2022-09-16 (version 5) |
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, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 66.09.42 | In distribution | |
| 62.00.10 | In distribution | |
| 62.00.13 | In distribution | |
| 62.00.21 | In distribution | |
| 67.06.76 | In distribution | |
| 66.09.02 | In distribution | |
| 66.03.01 | In distribution | |
| 67.03.50 | In distribution | |
| 67.06.55 | In distribution | |
| 62.01.37 | In distribution | |
| 66.03.02 | In distribution | |
| 67.05.56 | In distribution | |
| 67.02.75 | In distribution | |
| 66.02.01 | In distribution | |
| 66.01.11 | In distribution | |
| 66.09.01 | In distribution | |
| 67.06.75 | In distribution | |
| 66.05.53 | In distribution | |
| 66.05.52 | In distribution | |
| 66.01.10 | In distribution | |
| 62.00.22 | In distribution | |
| 62.03.15 | In distribution | |
| 66.03.51 | In distribution | |
| 62.03.14 | In distribution | |
| 66.05.92 | In distribution | |
| 66.07.02 | In distribution | |
| 66.05.03 | In distribution | |
| 66.07.03 | In distribution | |
| 66.08.27 | In distribution | |
| 66.07.01 | In distribution | |
| 62.00.20 | In distribution | |
| 66.08.03 | In distribution | |
| 66.05.51 | In distribution | |
| 66.05.32 | In distribution | |
| 62.00.25 | In distribution | |
| 62.00.23 | In distribution | |
| 67.03.52 | In distribution | |
| 62.03.12 | In distribution | |
| 67.02.55 | In distribution | |
| 990.04.21 | In distribution | |
| 66.07.00 | In distribution | |
| 62.03.11 | In distribution | |
| 62.01.66 | In distribution | |
| 67.05.76 | In distribution | |
| 66.08.07 | In distribution | |
| 66.03.53 | In distribution | |
| 66.08.29 | In distribution | |
| 66.03.52 | In distribution | |
| 62.01.02 | In distribution | |
| 66.05.02 | In distribution | |
| 66.05.31 | In distribution | |
| 62.00.15 | In distribution | |
| 66.08.05 | In distribution | |
| 66.02.02 | In distribution | |
| 66.08.09 | In distribution | |
| 67.02.35 | In distribution | |
| 66.05.01 | In distribution | |
| 66.08.57 | In distribution | |
| 62.00.11 | In distribution | |
| 66.08.53 | In distribution | |
| 66.08.55 | In distribution | |
| 67.05.55 | In distribution | |
| 62.01.38 | In distribution | |
| 62.01.31 | In distribution | |
| 66.02.03 | In distribution | |
| 62.03.00 | In distribution | |
| 62.01.36 | In distribution | |
| 62.00.24 | In distribution | |
| 62.01.39 | In distribution | |
| 62.03.65 | In distribution | |
| 62.01.10 | In distribution | |
| 62.01.01 | In distribution | |
| 66.03.03 | In distribution | |
| 62.01.30 | In distribution | |
| 66.08.24 | In distribution | |
| 71.65.70 | In distribution | |
| 66.08.59 | In distribution | |
| 62.01.12 | In distribution | |
| 66.09.41 | In distribution | |
| 62.03.16 | In distribution | |
| 67.02.90 | In distribution | |
| 66.09.43 | In distribution | |
| 62.03.13 | In distribution | |
| 62.01.00 | In distribution | |
| 67.05.75 | In distribution | |
| 66.09.03 | 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.