Integra 3
Assisted Reproduction Micromanipulator and Microinjector
3manufacturers in China registered for this device type
22catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Guangdong (2), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| Guangzhou Pinzhi Medical Device Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 5 |
Record
| Listed by | Research Instruments Ltd, United Kingdom |
|---|---|
| FDA product code | MQJ |
| Device type | Micromanipulators And Microinjectors, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6150 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K003142 |
| Record published | 2018-02-23 |
| Record revised | 2024-02-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Integra 3 Thermosafe Leica DMi 2 x SAS | In distribution | |
| Integra 3 Thermosafe Olympus 2 x SAS | In distribution | |
| Integra 3 Thermosafe Nikon 2 x SAS | In distribution | |
| Integra 3 Thermosafe Olympus IX1 No Syringes | In distribution | |
| Integra 3 Thermosafe Leica DMi No Syringes | In distribution | |
| Integra 3 no Thermosafe with ITO Leica DMi 2xSAS | In distribution | |
| Integra 3 Thermosafe Olympus 2 x SAS-SE | In distribution | |
| Integra 3 Thermosafe Nikon Ti2 2 x SAS-SE | In distribution | |
| Integra 3 Thermosafe Nikon 2 x SAS-SE | In distribution | |
| Integra 3 Thermosafe Olympus 1 x SAS & 1 x SAS-SE | In distribution | |
| INTEGRA 3 Micromanipulation System | In distribution | |
| Integra 3 Thermosafe Leica DMi 2 x SAS-SE | In distribution | |
| Integra 3 Thermosafe Nikon Ti2 2 x SAS | In distribution | |
| Integra 3 Thermosafe Nikon Ti2 No Syringes | In distribution | |
| Integra 3 No Thermosafe Leica DMI 2xSAS | In distribution | |
| INTEGRA 3 micromanipulation System with Thermosafe | In distribution | |
| Integra 3 Thermosafe Nikon No Syringes | In distribution | |
| Integra 3 Thermosafe Olympus IX1 2xSAS | In distribution | |
| Integra 3 Thermosafe Olympus No Syringes | In distribution | |
| Integra 3 Thermosafe Leica DMi 1 x SAS, 1 x SAS-SE | In distribution | |
| Integra 3 Thermosafe Nikon Ti2 1 x SAS 1 x SAS-SE | In distribution | |
| Integra 3 Thermosafe Nikon 1 x SAS & 1 x SAS-SE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LifeGlobal® Micropipet | LifeGlobal Group, LLC | 20 |
| Hariomed | HUA YUE Medical Technology Co., Ltd. | 4 |
| RI Syringe | Research Instruments Ltd | 3 |
| MTK-1VM-O2 | Narishige Lifemed Co., Ltd. | 1 |
| SFG Micropipettor | Spectrum Fertility Group Inc. | 1 |
| MMO-202NDVM | Narishige Lifemed Co., Ltd. | 1 |
| CellTram® vario | Eppendorf AG | 1 |
| MTK-1VM-Z3 | Narishige Lifemed Co., Ltd. | 1 |
| MTK-1VM-O1 | Narishige Lifemed Co., Ltd. | 1 |
| IM-9CVM | Narishige Lifemed Co., Ltd. | 1 |
| MTK-1VM-N3 | Narishige Lifemed Co., Ltd. | 1 |
| MTK-1VM-N4 | Narishige Lifemed Co., Ltd. | 1 |
Showing 12 of 42. All products under Micromanipulators And Microinjectors, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K003142 | 2000-11-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Research Instruments Ltd | 510(k) number | 2016-03-11 | Class II | Device Design | The units have been fitted with a potentially faulty power supply cable. | 380 units | 2021-03-02 |
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.