Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd.
Registered establishment in Shanghai, China. 9 device types.
Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Gown, Surgical, Mask, Surgical and 7 other device types. Its earliest product listing with the FDA dates from 1994.
Registration
| Registered name | Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016705853 |
| FEI number | 3016705853 |
| Establishment type | Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | F20,Tower1 ,Kerry Everbright City Enterprise Center |
| Postal code | 200070 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | 1994 | 439 |
| Continuous Measurement Thermometer | Class 2 | 2018 | 115 |
| Cover, Shoe, Operating-Room | Class 1 | 1999 | 176 |
| Dressing, Wound, Drug | Class U | 2013 | 48 |
| Gown, Isolation, Surgical | Class 2 | 2016 | 21 |
| Gown, Surgical | Class 2 | 2006 | 68 |
| Mask, Surgical | Class 2 | 2015 | 125 |
| Non-Surgical Gown | Class 1 | 2009 | 318 |
| Pump, Infusion, Enteral | Class 2 | 2018 | 5 |
Clearances
No clearance names Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd. as applicant. 9 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 |
|---|---|---|---|---|
| K160339 | 2016-07-28 | FYC | Traditional | Cardinal Health200, LLC |
| K150151 | 2015-05-21 | FYA | Traditional | Cardinal Health 200, LLC |
| K142990 | 2015-03-04 | FXX | Traditional | Cardinal Health200, LLC |
| K060649 | 2006-05-22 | FLL | Traditional | Tyco Healthcare Group LP |
| K040196 | 2004-05-05 | LZH | Traditional | Tyco Healthcare/Kendall |
| K023167 | 2002-10-02 | FYA | Special | Allegiance Healthcare Corp. |
| K020593 | 2002-03-18 | FYA | Special | Allegiance Healthcare Corp. |
| K011941 | 2001-08-22 | FRO | Traditional | The Kendall Company |
| K003313 | 2001-01-11 | FLL | Traditional | The Kendall Company |
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.