Data / Medical devices / Ireland / DMC Medical Ltd.
DMC Medical Ltd.: FDA-registered device maker in SHANNON Clare, Ireland, 2 510(k) clearances
DMC Medical Ltd. is registered with the FDA (registration 9616679) in SHANNON Clare, Ireland. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 10, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616679
- FEI number
- 3003057578
- Address
- Unit 5, Abbey House Shannon Town Centre, SHANNON Clare, Ireland, V14AH61
- Owner or operator
- DMC MEDICAL LTD. (9038387)
- Roles
- Exporter to the US, Specification developer
- First device listed
- August 20, 2003
- Registered through
- 2026
- Brand names listed
- 1/2 STRAIGHT CONNECTOR, 3/8 STRAIGHT CONNECTOR, CLEAR CONNECTOR, TINT CONNECTOR, HEARTNET, NuGen Syringe, Polycarbonate syringe, SUPRAGEL, Saphenous Vein Distention System, Y CONNECTOR, Y TINT CONNECTOR, Y CLEAR CONNECTOR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Stabilizer, Heart | MWS | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 10, 2011 | K103736 | DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE | FMF | Substantially Equivalent | Dmc Medical, Ltd. | accessdata.fda.gov |
| May 19, 2000 | K000704 | DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) | GBX | Substantially Equivalent | Dmc Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Catheter, Irrigation
- All makers of Stabilizer, Heart
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
Updated June 10, 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.