Data / Medical devices / Malaysia / Mediquip Sdn. Bhd.
Mediquip Sdn. Bhd.: FDA-registered device maker in Kangar Perlis, Malaysia, 6 510(k) clearances
Mediquip Sdn. Bhd. is registered with the FDA (registration 9611712) in Kangar Perlis, Malaysia. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 7, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611712
- FEI number
- 3002807574
- Address
- Padang Lati Mukim Paya Batu 5 Jalan Santan, Kangar Perlis, Malaysia, 02450
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Manufacturer
- First device listed
- December 17, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Urethral | GBM | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Urological | KOD | 2 | 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 |
|---|---|---|---|---|---|---|
| July 7, 2004 | K041243 | DOVER RED RUBBER ROBINSON CATHETER | KOD | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| September 28, 1999 | K990500 | KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C | EZL | Substantially Equivalent | The Kendal Co. | accessdata.fda.gov |
| August 12, 1988 | K881667 | KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH | GBM | Substantially Equivalent | The Kendal Co. | accessdata.fda.gov |
| March 11, 1986 | K860484 | CURITY & KENGUARD SILICONE COATED FOLEY CATHETER | KOD | Substantially Equivalent | The Kendal Co. | accessdata.fda.gov |
| March 31, 1981 | K810630 | SILICONE ELASTOMER COATED LATEX FOLEY | KOD | Substantially Equivalent | G.D. Searle and Co. | accessdata.fda.gov |
| December 16, 1980 | K802875 | ARGYLE HEMATURIA BALLOON CATHETER | KOD | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Urethral
- All makers of Catheter, Urological
- All makers of Catheter, Retention Type, Balloon
Updated July 7, 2004. 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.