Shanghai Gene Era Bio-Science Co., Ltd.
Registered establishment in Fengxian, Shanghai, China. 8 device types.
Shanghai Gene Era Bio-Science Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Non-Surgical Gown and 6 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3016919945 |
| FEI number | 3016919945 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Fengxian |
|---|---|
| Province | Shanghai |
| Address | No.211 East Huancheng Road |
| Postal code | 201400 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Gene | 2020 | 439 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class 1 | Gene | 2022 | 37 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Gene | 2022 | 72 |
| General Purpose Reagent | Class 1 | GENE Nucleic acid pretreatment reagent | 2024 | 30 |
| Mask, Oxygen | Class 1 | 2023 | 126 | |
| Microtitrator, For Clinical Use | Class 1 | Gene | 2023 | 1 |
| Non-Surgical Gown | Class 1 | Gene | 2020 | 318 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Gene | 2020 | 384 |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 20,000 m² |
|---|---|
| Main products | Robotic Tips, Pipette Tips, PCR Series, Tubes, Deep Well Plates |
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.