FDA Registration
Active
🇨🇳 China
Shanghai Gene Era Bio-Science Co., Ltd.
Reg #: 3016919945
·
FEI: 3016919945
·
Expires 2026
Products
8
Proprietary Names
2
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Shanghai Gene Era Bio-Science Co., Ltd.
- Registration Number
- 3016919945
- FEI Number
- 3016919945
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.211 East Huancheng Road
- City
- Fengxian Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- Shanghai Gene Era Bio-Science Co., Ltd.
- Operator Number
- 10066778
- Address
- No.211 East Huancheng Road
- City
- Fengxian
- State
- Shanghai
- Postal Code
- 201400
- Country
- CN
- Correspondent
- Ziyan Zhang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-04-02 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2022-02-21 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-02 |
| Microtitrator, For Clinical Use | JRA | Class 1 | Clinical Chemistry | No | 2023-01-17 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2022-02-21 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-02 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2023-01-17 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2024-02-28 |
Proprietary Names
Gene
GENE Nucleic acid pretreatment reagent
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)