Inka
KILLIAN Septum Speculum sz:2 55mm 15cm -fiber optic light carrier
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1), Hubei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Hubei Qifu Protective Products Co., Ltd. | Xiantao | Hubei | Manufacturer | 9 |
Record
| Listed by | The Trustee for Kaiser Family Trust |
|---|---|
| FDA product code | FXF |
| Device type | Speculum, Illuminated |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Premarket notification | Exempt |
| Record published | 2025-12-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 33136.55 FOL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Digital Medical Scope | Nidek Incorporated | 2 |
| EZY Dose Kids | Apothecary Products, LLC. | 1 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 1 |
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.