Data / Medical devices / Singapore / Cardinal Health Singapore 225 Pte Ltd
Cardinal Health Singapore 225 Pte Ltd: FDA-registered device maker in SINGAPORE Central Singapore, Singapore, 8 510(k) clearances
Cardinal Health Singapore 225 Pte Ltd is registered with the FDA (registration 3005674464) in SINGAPORE Central Singapore, Singapore. It lists 10 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 16, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005674464
- Address
- 2 Tanjong Katong Road #05-01 Plq3, SINGAPORE Central Singapore, Singapore, 437161
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Exporter to the US
- First device listed
- May 7, 2002
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter And Tip, Suction | JOL | 2 | Exporter to the US | accessdata.fda.gov |
| Catheter, Urological | KOD | 2 | Exporter to the US | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US | accessdata.fda.gov |
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Exporter to the US | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Exporter to the US | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Exporter to the US | accessdata.fda.gov |
| Pump, Infusion, Enteral | LZH | 2 | Exporter to the US | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| May 16, 2017 | K163002 | Kangaroo Feeding Tube with IRIS Technology | KNT | Substantially Equivalent | Covidien (Dba Medtronic) | accessdata.fda.gov |
| September 1, 2016 | K161963 | Monoject Enteral Syringe with ENFit Connector | PNR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 9, 2014 | K123555 | KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY | KNT | Substantially Equivalent | Covidien | accessdata.fda.gov |
| February 26, 2009 | K082296 | COPA AMD | FRO | Substantially Equivalent | Covidien Lp, Formerly Registered AS Tyco Healthcar | accessdata.fda.gov |
| May 5, 2004 | K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | LZH | Substantially Equivalent | Tyco Healthcare/Kendall | accessdata.fda.gov |
| August 22, 2001 | K011941 | EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 | FRO | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
| January 31, 2000 | K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING | NAD | Substantially Equivalent | The Kendall Company, L.P. | accessdata.fda.gov |
| February 9, 1981 | K810216 | ARGYLE ROB-NELS | KOD | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Infusion, Enteral
- All makers of Dressing, Wound, Occlusive
- All makers of Catheter And Tip, Suction
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Dressing, Wound, Drug
Updated May 16, 2017. 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.