Haimen Shengbang Laboratory Equipment Co., Ltd.
Registered establishment in Haimen, Jiangsu, China. 17 device types.
Haimen Shengbang Laboratory Equipment Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Micro Pipette, Suit, Surgical and 15 other device types. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | HAIMEN SHENGBANG LABORATORY EQUIPMENT CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011676045 |
| FEI number | 3011676045 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 海门市盛邦实验器材有限公司 |
|---|---|
| Source | Chinese medical device directory |
Location
| City | Haimen |
|---|---|
| Province | Jiangsu |
| Address | No.126,Team 9, Zhangbei Village |
| Postal code | 226113 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | face mask | 2020 | 439 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Swabs/Swabs with medium | 2015 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Sterile Swabs, oral swabs,nasal swabs,flocking swabs | 2020 | 100 |
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | Biopsy Cassette/Embedding Cassette | 2015 | 51 |
| Container, Specimen Mailer And Storage, Sterile | Class 1 | Specimen container/urine container/stool container/sputum cup, vacuum urine container,, urine collection tube, specimen collection kit, urine collection kit bags | 2015 | 33 |
| Container, Specimen, Non-Sterile | Class 1 | Vacuum Urine Container,Urine Transfer Straw,URINE SPECIMEN COLLECT KIT, Sample Collection Kit, vacuum urine container, Storage Box for Slide, Urine Test Tube, storage box for pipette tips, storage box for cryo tube, specimen container/urine container/stool container/sputum cup,, Vaccum Urine Tube and 1 more | 2015 | 115 |
| Coverslips, Microscope Slide | Class 1 | Microscope Slides /Cover glasses | 2015 | 32 |
| Culture Media, Non-Selective And Non-Differential | Class 1 | Salvia Collecting Kit, sampling collector, flocking swabs | 2021 | 18 |
| Dish, Tissue Culture | Class 1 | petri dish, Culture Plate/Tissue Culture Plate, Deep well plate | 2015 | 30 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | centrifuge tube, cryo tube, Cell Spreader , Loops, PCR Tube, PCR plate , Test Tube, Cryogenic Tubes (Brand: medrock26), Blood collection tube Holder | 2015 | 72 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | face mask | 2020 | 182 |
| Micro Pipette | Class 1 | pipette tips | 2015 | 29 |
| Pipette, Pasteur | Class 1 | pipette | 2015 | 20 |
| Punch, Gelfoam, Non-Sterile | Class 1 | Specimen collection kit | 2024 | 2 |
| Slides, Microscope | Class 1 | Slides | 2024 | 26 |
| Suit, Surgical | Class 1 | face mask | 2020 | 74 |
| Tray, Surgical, Instrument | Class 1 | centrifuge tube rack, Test Tube Rack, Staining Jar and Racks | 2015 | 105 |
Recalls
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 3 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-07-12 | Class I | No Marketing Application | Distributed VTM outside of VTM Guidance and without clearance. | 8,710,600total units |
| 2022-07-12 | Class I | No Marketing Application | Distributed VTM outside of VTM Guidance and without clearance. | 100,000 total units |
| 2022-07-12 | Class I | No Marketing Application | Distributed VTM outside of VTM Guidance and without clearance. | 3,950,000 total units |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Main products | Centrifuge tubes, Pipette tips, Culture plates, Cryovials |
| Certifications | ISO 13485, CE |
| Export markets | US, EU, Asia |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Citotest Labware Manufacturing Co., Ltd. | 46 |
| Nantong City Yojo Medical Products Co., Ltd. | 14 |
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.