Koo (Shanghai) Industries Co., Ltd.
Registered establishment in Songjiang, Shanghai, China. 9 device types, 2 clearances.
Koo (Shanghai) Industries Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Mask, Gas, Anesthetic and 7 other device types. Its earliest product listing with the FDA dates from 1999.
Registration
| Registered name | Koo (Shanghai) Industries Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007963782 |
| FEI number | 3007963782 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Songjiang |
|---|---|
| Province | Shanghai |
| Address | 100 Zhongde Road |
| Postal code | 201614 |
| Country | China |
Group
Koo (Shanghai) Industries Co., Ltd. is one of 2 plants registered under KOO MFG, INC..
| Plant | City | Device types |
|---|---|---|
| KOO Medical Equipment (Shanghai) Co., Ltd. | Songjiang | 2 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | Class 1 | First Breath Nasal Oxygen Cannula with female luer connector, tubing and oxgyen adapter, First Breath Nasal Oxygen Cannula with gas monitoring line, male luer connector, tubing, oxygen adapter, First Breath Nasal Oxygen Cannula with male luer connector, tubing and oxygen connector, First Breath Nasal Oxygen Cannula with ETCO2 monitoring, First Breath Nasal Oxygen Cannula with gas monitoring line, female luer connector, tubing, oxygen adapter, Oxygen Nasal Cannula | 2005 | 97 |
| Holding Chambers, Direct Patient Interface | Class 2 | 2016 | 3 | |
| Mask, Gas, Anesthetic | Class 1 | Face Mask, Aria Blow Mold Mask, Crystal Anesthesia Mask | 1999 | 71 |
| Mask, Oxygen | Class 1 | Tracheostomy Mask, Oxygen Mask with Reservoir Bag, face tent, Drainage Bag with ‘T’ connector, Aerosol Mask, Oxygen Mask and 7 more | 2005 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Venturi Oxygen Mask, Tracheostomy Venturi Oxygen Mask, Venturi Mask | 2013 | 46 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Oxygen Mask, NON-Rebreathing, Elongated Non-Rebreather Oxygen Mask | 2005 | 72 |
| Prostate Immobilizer Rectal Balloon | Class 2 | Prostate Caddy™ | 2015 | 1 |
| Syringe, Irrigating (Non Dental) | Class 1 | Inflation Syringe for Rectal Balloon, Mask Inflation Bulb, Bulb Syringes | 2006 | 110 |
| Tubing, Pressure And Accessories | Class 1 | Oxygen Tubing | 2010 | 45 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K112041 | 2011-12-22 | CAF | Traditional | This company |
| K101136 | 2011-01-28 | NVP | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1993 |
|---|---|
| Main products | Anesthesia devices, Respiratory care devices |
| Certifications | FDA, ISO13485 |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| BQ Plus Medical Co., Ltd. | 13 |
| KOO Medical Equipment (Shanghai) Co., Ltd. | 2 |
| Shanghai Gangkai Purifying Products Co., Ltd. | 1 |
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.