Medical & Healthcare Supplies Manufacturers & Suppliers in Ireland

Galway, Ireland

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 5 medical devices: Aerogen Pro-X1 Controller System (K251615, 2025-09-02), Aeroneb USB Contoller System (K143719, 2015-07-10), AERONEB SOLO; AERONEB SOLO ADAPTER (K133360, 2014-10-17) +2. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Dublin, Ireland

• Registered as a manufacturer · Superintendencia de Regulacion Sanitaria de El Salvador

Spiddal, Ireland

Loughrea, Ireland

Waterford, Ireland

• Medicines manufacturing or import authorisation (MIA) · EudraGMDP manufacturing and importation authorisation register

Dublin, Ireland

Dublin, Ireland

• Registered with the U.S. FDA (active, renewed for the current year)

Dublin, Ireland

• Registered as a manufacturer · ALIMS
• Registered with the U.S. FDA (active, renewed for the current year)

Galway, Ireland

• Applicant to the US FDA for 4 medical devices: NEUROMARK System (NMK00301) (K261833, 2026-06-16), NEUROMARK System (NMK00301) (K250048, 2025-05-29), NEUROMARK System (K222032, 2022-10-26) +1. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Registered with the U.S. FDA (active, renewed for the current year)

Dublin, Ireland

Croom, Ireland

Bishopstown, Ireland

Cork, Ireland

Little Island, Ireland

Co Cork, Ireland

Ireland

Dublin, Ireland

• Registered as a manufacturer · ALIMS

Galway, Ireland

Mullingar, Ireland

Galway, Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Applicant to the US FDA for 4 medical devices: Enroute 0.014'' Transcarotid Guidewire (K253746, 2026-03-19), ENROUTE 0.014 Guidewire (K160643, 2016-10-18), HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE (K140536, 2014-12-17) +1. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Shannon, Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Registered with the U.S. FDA (active, renewed for the current year)

Ireland

Ireland

• Registered as a manufacturer · Agencia Estatal de Medicamentos y Tecnologias en Salud
• Registered with the U.S. FDA (active, renewed for the current year)

Ireland

• Listed in The Companies Registration Office – an Oifig um Chlarú Cuideachtaí; entry number 401268. Matched to this company by name only; no second anchor confirms it is the same legal entity. · BRIS

Galway, Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Registered with the U.S. FDA (active, renewed for the current year)

Ringaskiddy, Ireland

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 40 medical devices: ATTUNE Total Knee System; ATTUNE Cementless Knee System (K261458, 2026-06-25), Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement (K260536, 2026-05-15), INHANCE™ Reverse Shoulder System (K253624, 2026-03-11) +37. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Registered with the U.S. FDA (active, renewed for the current year)

Athlone, Ireland

• Registered with the U.S. FDA (active, renewed for the current year)

Cork, Ireland

Cork, Ireland

• Registered with the U.S. FDA (active, renewed for the current year)

Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Registered with the U.S. FDA (active, renewed for the current year)

Longford, Ireland

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 5 medical devices: Cholesterol2 (K203597, 2022-06-30), Urea Nitrogen2 (K203771, 2022-05-31), Creatinine2 (K210452, 2022-03-22) +2. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Sligo, Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

BallyBrit Galway, Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Waterford, Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Kells Meath, Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Co. Sligo Connaught, Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Longford, Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Applicant to the US FDA for 1 medical devices: BeneHold™ Surgical Incise Drape with CHG antimicrobial II (K230645, 2023-10-25). The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

O CALLAGHANS MILLS Clare, Ireland

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 3 medical devices: Ceruloplasmin (K161508, 2017-01-09), Beta-2-Microglobulin (K161297, 2016-06-07), Urine/CSF Albumin, Urine/CSF Albumin Calibrator (K142346, 2014-10-15). The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Roscommon, Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

GALWAY, Ireland

• Registered as a manufacturer · ALIMS
• Applicant to the US FDA for 8 medical devices: HYDRAVIEW GUIDEWIRE (K141831, 2014-09-04), CHARTER GUIDEWIRE (K122856, 2012-10-17), VICTORY GUIDEWIRE (32 MODELS) (K120137, 2012-02-14) +5. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510

Galway, Ireland

• Registered with the U.S. FDA as a Contract Manufacturer
• Site address listed in a government regulator's register · US FDA device establishment registration

Wexford, Ireland

• Applicant to the US FDA for 5 medical devices: BANTAM CATHETER (280MM BALLOON LENGTHS) (K112335, 2011-10-12), SLEEK OTW PTA CATHETERS (K102035, 2010-12-01), LITEPAC, MODEL 682 (K100490, 2010-03-16) +2. The applicant answers for the notification; the record does not say who makes the device · FDA premarket notifications 510
• Site address listed in a government regulator's register · US FDA device establishment registration

Co. Galway, Ireland

• Site address listed in a government regulator's register · US FDA device establishment registration
• Registered with the U.S. FDA (active, renewed for the current year)

Mullingar, Ireland

• Registry ID checks out with the state register · Companies Registration Office

Kinsale Road, Ireland

• Registry ID checks out with the state register · Companies Registration Office

Cork, Ireland

County Dublin, Ireland