Shanghai NEO-Medical Import & Export Co., Ltd.
Manufacturer and brand owner in Shanghai, China. 59 device types, 4 products catalogued, 1 clearance.
Shanghai NEO-Medical Import & Export Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Bedpan, Urinal and 57 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2005.
Registration
| Registered name | SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005327291 |
| FEI number | 3005327291 |
| DUNS | 421090090 |
| Establishment type | Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Rm2004 B/D3 ,183 Huaihai xi Rd |
| Postal code | 200030 |
| Country | China |
What It Makes
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Face Mask tie on | FXX | 1 |
| Face Mask with shield earloop | FXX | 1 |
| Face Mask earloop | FXX | 1 |
| Face Mask with shield tie on | FXX | 1 |
Clearances
1 clearance names Shanghai NEO-Medical Import & Export Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K111559 | 2011-09-16 | FXX | Traditional | This company |
| K162590 | 2017-02-14 | ILY | Traditional | Chogqing Yuhe Medical Instruments Co., Ltd. |
| K041954 | 2004-09-15 | DRX | Traditional | Shanghai Intco Electrode Manufacturing Co Ltd |
| K950780 | 1995-07-25 | HHT | Traditional | Amsino Medical Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Non-woven products, Wound care products, Adhesive bandages, Surgical trays, Electrocardiograph electrodes |
|---|---|
| Certifications | ISO 9001:2000, ISO 13485:2003, CE, TUV, FDA |
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.