Data / Medical devices / China / Koo (Shanghai) Industries Co., Ltd
Koo (Shanghai) Industries Co., Ltd: FDA-registered device maker in Songjiang Shanghai, China, 1 510(k) clearance
Koo (Shanghai) Industries Co., Ltd is registered with the FDA (registration 3007963782) in Songjiang Shanghai, China. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 28, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007963782
- Address
- 100 Zhongde Road Xiaokunshan Town, Songjiang Shanghai, China, 201614
- Owner or operator
- KOO MFG, INC. (9012237)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 13, 1999
- Registered through
- 2026
- Brand names listed
- AEROSOL, ARIA BLOW MOLD MASK, Aerosol Mask, BLUESTAR PLUS FACE MASK, BULB SYRINGES, CRYSTAL ANESTHESIA MASK, DELUXE NASAL, Drainage Bag and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Holding Chambers, Direct Patient Interface | NVP | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Manufacturer | accessdata.fda.gov |
| Prostate Immobilizer Rectal Balloon | PCT | 2 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 28, 2011 | K101136 | FISIO CHAMBER SPACE | NVP | Substantially Equivalent | Koo (Shanghai) Industries Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Prostate Immobilizer Rectal Balloon
- All makers of Cannula, Nasal, Oxygen
- All makers of Mask, Oxygen
- All makers of Mask, Oxygen, Low Concentration, Venturi
- All makers of Mask, Gas, Anesthetic
Updated January 28, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.