31 results · 19ms · Sources: EU EUDAMED, US FDA

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Aerogen Ltd

Manufacturer
🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·National Standards Authority of Ireland (NSAI)

Medifill Ltd

Manufacturer
🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·National Standards Authority of Ireland (NSAI)

Syncrophi Systems Ltd

Manufacturer
🇮🇪 Ireland·1 Basic UDI-DI·1 Device·National Standards Authority of Ireland (NSAI)

CutisSeal Topical B

Device
EU MDD · Eu Md Class 2a ·Medifill Ltd·On the market·1 country

CutisSeal Topical H

Device
EU MDD · Eu Md Class 2a ·Medifill Ltd·On the market·1 country

KEWS300

Device
EU MDD · Eu Md Class 2b ·Syncrophi Systems Ltd·On the market·1 country

Aerogen USB Controller

Device
EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·7 countries

Aerogen USB Controller

Device
EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·1 country

Aerogen Ultra (10 Pack)

Device
EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·1 country

Aerogen Solo Adult T-Piece 22mm

Device
EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·13 countries

Aerogen Solo Nebuliser (10 Pack)

Device
EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·25 countries

ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.

FDA Enforcement
Class II ·Terminated·Abbott Ireland Diagnostics Division·December 3, 2014

KEWS300

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Syncrophi Systems Ltd·1 device

CutisSeal Topical B

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Medifill Ltd·1 device

CutisSeal Topical H

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Medifill Ltd·1 device

AG-AS3200

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Aerogen Ltd·1 device

AG-AS3010

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Aerogen Ltd·1 device

AG-UC1000-NE

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Aerogen Ltd·1 device

AG-UC1000-IN

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Aerogen Ltd·1 device

AG-AS7000-EU

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Aerogen Ltd·1 device