Labotect
Single packed
5manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Sichuan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| UKS Medical Technology (Chongqing) Co., Ltd. | Chongging | Sichuan | Contract manufacturer | 4 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| CGN Gray (Shenzhen) Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Guangzhou Hehong Biotech Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 2 |
Record
| Listed by | Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | MQF |
| Device type | Catheter, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6110 |
| 510(k) | K000950 |
| Record published | 2019-10-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Cardboard box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Insemination Catheter | In distribution | |
| Embryo Transfer Catheter 19 cm | In distribution | |
| Embryo Transfer Catheter 23 cm | In distribution | |
| Embryo Transfer Catheter 19 cm | In distribution | |
| Embryo Transfer Catheter 15 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kitazato ET Catheter | Kitazato Corporation | 53 |
| Soft-Pass | Cook Incorporated | 21 |
| kitazato IUI Catheter | Kitazato Corporation | 20 |
| Soft-Trans | Cook Incorporated | 20 |
| Guardia | Cook Incorporated | 15 |
| Wallace | ICU Medical, Inc | 12 |
| Intrauterine insemination cannula | Gynetics Medical Products NV | 8 |
| Catheter, Assisted Reproduction | C R I | 8 |
| Minvitro Embryo Transfer Catheter | Guangzhou Hehong Biotech Co., Ltd. | 6 |
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 5 |
| Microvol | Cook Incorporated | 5 |
| Tefcat | Cook Incorporated | 4 |
Showing 12 of 111. All products under Catheter, Assisted Reproduction
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.