Bioteque
16 catalogue numbers from UMI4.5K-G, listed by Bioteque Taiwan Ltd., Taiwan, under Cannula, Manipulator/Injector, Uterine. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2), Beijing (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 |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Tonglu Qianyan Medtech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Beijing Hangtian Kadi Technology R&D Institute | Beijing | Beijing | Manufacturer | 5 |
Record
| Listed by | Bioteque Taiwan Ltd., Taiwan |
|---|---|
| FDA product code | LKF |
| Device type | Cannula, Manipulator/Injector, Uterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Contract steriliser, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K092980 |
| Record published | 2024-12-06 |
| Record revised | 2026-07-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 12, box of 10, box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UMI4.5K-G | In distribution | |
| UMI4.5KC | In distribution | |
| UI 4.0 | In distribution | |
| UIC5FAX | In distribution | |
| BA07F | In distribution | |
| BA051F | In distribution | |
| UIC5FA | In distribution | |
| UMI4.5-P | In distribution | |
| BA071F | In distribution | |
| BA05F | In distribution | |
| UMI4.5K | In distribution | |
| UMI4.5C | In distribution | |
| UIC5F | In distribution | |
| BA001 | In distribution | |
| UMI4.5 | In distribution | |
| BA05F-ST | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 39 |
| Cannula, Manipulator/Injector, Uterine | C R I | 31 |
| Marina Medical | Marina Medical Instruments, Inc. | 29 |
| HSG Catheter | Titus Medical LLC | 26 |
| HNM Women Care | HNM Stainless, LLC. | 20 |
| Viky | Endocontrol | 15 |
| Cannula, Manipulator/Injector, Uterine | Panpac Medical Corporation | 14 |
| Uterine ElevatOR Pro | THE O R Company PTY Ltd | 12 |
| Valtchev Uterine Mobilizer | Conkin Surgical Instruments Ltd. | 10 |
| Novo Surgical | Novo Surgical, Inc. | 9 |
| McCarus-Volker Fornisee® System | LSI Solutions Inc. | 9 |
| Cook | Cook Incorporated | 8 |
Showing 12 of 111. All products under Cannula, Manipulator/Injector, Uterine
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.