Changsha Renji Medical Equipment Co., Ltd.
Registered establishment in Changsha, Hunan, China. 15 device types.
Changsha Renji Medical Equipment Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Micro Pipette, Pipette, Pasteur and 13 other device types. Its earliest product listing with the FDA dates from 2021.
Registration
| Registered name | CHANGSHA RENJI MEDICAL EQUIPMENT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3018779125 |
| FEI number | 3018779125 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 长沙仁基医疗器械有限公司 |
|---|---|
| Unified social credit code | 91430181MA4RPFWQ23 |
| Source | NMPA UDI database |
Location
| City | Changsha |
|---|---|
| Province | Hunan |
| Address | 201, Stage 4, Changsha E Center, No.18 Xiangtai Road, Liuyang Jingkai District |
| Postal code | 410329 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | Class 1 | Specimen Collection Flocked Swabs, Disposable Sampling Swab | 2021 | 100 |
| Clinical Sample Concentrator | Class 1 | Viral RNA&DNA Extraction Kit; Sample Release Kit | 2023 | 27 |
| Container, Specimen Mailer And Storage, Sterile | Class 1 | Disposable Stool Container, Saliva Collection Kit, Sample Container, Disposable Urine Container, Disposable Urine Tube | 2023 | 33 |
| Container, Specimen, Non-Sterile | Class 1 | Disposable Urine Container, Disposable Urine Tube, Biosafety Bag, Sample Container, Disposable Stool Container, Saliva Collection Kit | 2023 | 115 |
| Container, Specimen, Sterile | Class 1 | Saliva collection kits, Sample Container, Disposable Stool Container, Disposable Urine Tube, Disposable Urine Container | 2021 | 79 |
| Culture Media, Non-Propagating Transport | Class 1 | Viral Transport Medium(VTM) Swab Kits, Disposable Virus Specimen Collection Tube | 2021 | 11 |
| Culture Media, Non-Selective And Non-Differential | Class 1 | Disposable Virus Specimen Collection Tube | 2021 | 18 |
| Dish, Tissue Culture | Class 1 | Petri Dish | 2023 | 30 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Deepwell Plate, Centrifuge Tube, Cryovials, Test Tube, PCR Tube | 2023 | 72 |
| Micro Pipette | Class 1 | Pipette Tip | 2023 | 29 |
| Pipette, Pasteur | Class 1 | Serological Pipette, Transfer Pipette | 2023 | 20 |
| Speculum, Vaginal, Nonmetal | Class 2 | Disposable Vaginal Speculum | 2023 | 40 |
| System, Blood Collection, Vacuum-Assisted, Manual | Class 1 | Blood Collection Tube | 2023 | 31 |
| Tourniquet, Nonpneumatic | Class 1 | Disposable Automatic Venous Compression Band | 2023 | 124 |
| Transport Medium, Notified Per The Vtm Guidance | Class 1 | Viral Transport Medium(VTM) Swab Kits, Disposable Virus Specimen Collection Tube, Saline Transport Medium | 2021 | 5 |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 48,641.96 m² |
|---|---|
| Main products | Blood Collection Tube, Disposable Vaginal Speculum, Virus Specimen Collection Tube, Sampling Swab, Urine Container |
| Certifications | ISO 13485, ISO 9001, CE, NMPA approval |
| Export markets | Over 50 countries |
| OEM and ODM | Offered |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.