FDA Registration
Active
🇮🇪 Ireland
DMC MEDICAL LTD.
Reg #: 9616679
·
FEI: 3003057578
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- DMC MEDICAL LTD.
- Registration Number
- 9616679
- FEI Number
- 3003057578
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- UNIT 5, ABBEY HOUSE, SHANNON TOWN CENTRE
- City
- SHANNON Clare
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K000704
Owner / Operator
- Firm Name
- DMC MEDICAL LTD.
- Operator Number
- 9038387
- Address
- UNIT 5, ABBEY HOUSE, SHANNON TOWN CENTRE
- City
- SHANNON
- State
- Clare
- Postal Code
- --
- Country
- IE
- Correspondent
- Bryan - Wixted
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive, Hampton
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2008-03-31 |
| Stabilizer, Heart | MWS | Class 1 | Cardiovascular | No | 2006-12-15 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2005-03-28 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2011-06-30 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2003-08-20 |
Proprietary Names
Saphenous Vein Distention System
HEARTNET
SUPRAGEL
Syringe
1/2 STRAIGHT CONNECTOR
Y CONNECTOR, Y TINT CONNECTOR, Y CLEAR CONNECTOR
3/8 STRAIGHT CONNECTOR, CLEAR CONNECTOR, TINT CONNECTOR
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device