Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616679

FEI Number

3003057578

Entity Name

DMC MEDICAL LTD.

City/State/Country

SHANNON Clare, IE

Establishment Address

UNIT 5, ABBEY HOUSE, SHANNON TOWN CENTRE, SHANNON Clare V14AH61, IE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

DMC MEDICAL LTD. (Owner Number: 9038387)

Owner / Operator Contact Address

UNIT 5, ABBEY HOUSE, SHANNON TOWN CENTRE, SHANNON, IE-CE --, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2008-03-31
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2006-12-15
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2005-03-28
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2011-06-30
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2003-08-20

Official Correspondent

Bryan Wixted

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

DMC MEDICAL LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3032912826	KMD SURGICAL SOLUTIONS, INC.	Winston Salem, NC, US
3017435705	CENTESE, INC.	Omaha, NE, US
1057421	GRACE MEDICAL, INC.	Memphis, TN, US
2521402	B. BRAUN MEDICAL INC.	BETHLEHEM, PA, US
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616679. Last updated year: 2026. Please use registration number 9616679 when referencing this establishment in official correspondence.