Wuxi Nest Biotechnology Co., Ltd.
Manufacturer and brand owner in Wuxi, Jiangsu, China. 2 device types, 1 product catalogued, 4 clearances.
Wuxi Nest Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Syringe, Piston, Nasal Spray, Ent Delivery. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
2device types registered with the FDA
1product
4510(k) clearances
Registration
| Registered name | WUXI NEST BIOTECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009302820 |
| FEI number | 3009302820 |
| DUNS | 528156364 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 无锡耐思生命科技股份有限公司 |
|---|---|
| Unified social credit code | 91320213685882797G |
| Source | NMPA UDI database |
Location
| City | Wuxi |
|---|---|
| Province | Jiangsu |
| Address | No. 530, Xida Road, Meicun Industrial Park, Xinwu District |
| Postal code | 214112 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Nasal Spray, Ent Delivery | Class 1 | Disposable Intranasal Atomization Device | 2022 | 23 |
| Syringe, Piston | Class 2 | Disposable Pen Injector Assembly, Pen Injector | 2024 | 60 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Nest | FMF | 16 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240961 | 2024-08-15 | FMF | Traditional | This company |
| K240774 | 2024-06-18 | FMF | Traditional | This company |
| K211256 | 2022-05-20 | JSM | Traditional | This company |
| K210440 | 2021-09-20 | QBD | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Factory area | 16500 m² |
| Main products | Cell culture plasticware, Bioprocess solutions, Medical delivery systems, Molecular diagnostics, Liquid handling consumables |
| Certifications | ISO 9001, ISO 13485, ISO 11137, FDA, CE |
| Export markets | North America, Europe, Southeast Asia, Middle East, Japan, Korea, India |
| 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.