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GCE, s.r.o.

US

Last updated May 23, 2026

What GCE, s.r.o. makes

GCE, s.r.o. manufactures medical gas delivery systems, including non-fixed and fixed cylinder regulators for gases like oxygen and air, as well as low-pressure hoses and tubing for respiratory and general medical gas applications. Their portfolio also includes Thorpe tube flowmeters for precise gas measurement and vacuum suction regulators for clinical use.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to regulatory requirements for medical gas equipment.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does GCE, s.r.o. primarily manufacture?

GCE, s.r.o. specializes in medical gas delivery systems, focusing on components like non-fixed and fixed medical gas cylinder regulators (for gases such as oxygen and air), low-pressure hoses and tubing for respiratory and general medical gas applications, and Thorpe tube flowmeters for precise gas measurement. Their portfolio also includes vacuum suction regulators for clinical use, ensuring safe and controlled gas flow in healthcare settings.

Where is GCE, s.r.o. based, and does this location impact its regulatory compliance?

GCE, s.r.o. is based in the United States. Since its devices are subject to U.S. regulatory requirements—such as FDA classification and UDI listing—its location ensures alignment with domestic medical device regulations, including manufacturing, labeling, and post-market surveillance standards for medical gas equipment.

Which regulatory registries or databases list GCE, s.r.o.’s devices?

GCE, s.r.o.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory oversight and patient safety.

How are GCE, s.r.o.’s medical devices classified under FDA regulations?

GCE, s.r.o.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls (e.g., labeling, manufacturing practices), while Class II devices involve moderate risk and may require special controls (e.g., performance standards or post-market surveillance) to ensure safety and effectiveness. Classification depends on factors like the device’s intended use and potential harm.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
819753190

Catalogue (148)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
Vm+ O2 Cga870 _ _ 9/16 S 0729109US
FDA UDI
Class IActive
Varimed+ VM+ O2 CGA540 _ _ 9/16 S
FDA UDI
Class IActive
Mfu2 _ O2 Ds _ 9/16 G 0728107US
FDA UDI
Class IActive
Vm+ O2 Cga540 _ _ 9/16 G 0729101US
FDA UDI
Class IActive
Varimed VM N2O CGA326 DS _ _ S
FDA UDI
Class IActive
Varimed+ VM+ N2O CGA326 DS _ _ S
FDA UDI
Class IActive
Ms25 O2 Cga540 Ds _ 9/16 G 0720103US
FDA UDI
Class IActive
Ms6 O2 Pi Ds _ 9/16 G 0720102US
FDA UDI
Class IActive
Varimed VM O2 CGA540 _ _ 9/16 S
FDA UDI
Class IActive
Varimed+ VM+ CO2 PI DS _ _ S
FDA UDI
Class IActive
Mfu2 _ O2 Ch _ 9/16 G 0728112US
FDA UDI
Class IActive
Mfu15 _air Oh _ 9/16 G 0728116US
FDA UDI
Class IActive
Mcn Air Y2 Dsf Ds G 0731008US
FDA UDI
Class IActive
Mft25 O2 Ds _ _9/16 S 0726502US
FDA UDI
Class IUnknown
Mr Air Cga346 Ds _ _ G 0724103US
FDA UDI
Class IActive
MediVitop MT25 O2 3/4UNF CGA540R DS S
FDA UDI
Class IActive
Mr O2 Cga540 Ds _ _ G 0724102US
FDA UDI
Class IActive
MediConnect MCN O2 G1 DSF DSF G
FDA UDI
Class IUnknown
MediVital E MVE25 O2 3/4UNF CGA540 DS S
FDA UDI
Class IActive
Me+600 _ Ds _ G1/2 G 0735102US
FDA UDI
Class IIActive
Varimed VM N2O CGA326 _ _ 9/16 S
FDA UDI
Class IActive
Mcn Air Y1 Dsf Ds G 0731006US
FDA UDI
Class IActive
Mtc6 O2 Pi Ds _ 9/16 S 0721108US
FDA UDI
Class IActive
Ms25 O2 Pi _ _ 9/16 S 0720117US
FDA UDI
Class IActive
Mfu15 _ O2 Oh _ 9/16 G 0728110US
FDA UDI
Class IActive
Mcn Vac W1 Dsf Ds G 0731010US
FDA UDI
Class IActive
Mtc25 O2 Cga540 Ds _ 9/16 S 0721109US
FDA UDI
Class IActive
Mm5 _o2 Ds _ 9/16unf S 0730109US
FDA UDI
Class IActive
Ms6 O2 Cga540 Ds _ 9/16 G 0720104US
FDA UDI
Class IActive
Mcn Air Y1 Dsf Dsf G 0731005US
FDA UDI
Class IActive
Vm O2 G5/8bs _ _ G1/4 G 0729112US
FDA UDI
Class IActive
Mm5 _o2 Ds _ 9/16unf G 0730102US
FDA UDI
Class IActive
Mcn O2 G2 Dsf Dsf S 0731015US
FDA UDI
Class IActive
Ms25 O2 Pi _ _ 9/16 G 0720107US
FDA UDI
Class IActive
Ms25 O2 Cga540 Ds _ 9/16 S 0720123US
FDA UDI
Class IActive
Mcn O2 G2 Dsf Dsf G 0731003US
FDA UDI
Class IActive
Mtc6 Air Cga346 Ds _ 9/16 G 0721106US
FDA UDI
Class IActive
Varimed+ VM+ O2 CGA870 _ _ 9/16 S
FDA UDI
Class IActive
Mm15 Dy O2 Ds _ 9/16 G 0730103US
FDA UDI
Class IActive
MediReg II MR15F O2 CGA540_ _ 9/16 G
FDA UDI
Class IUnknown
Mfu25 _ O2 Dn _ 9/16 S 0728106US
FDA UDI
Class IActive
Mtc25 Air Cga346 Ds _ 9/16 S 0721111US
FDA UDI
Class IActive
Mr Air Cga346 Ds _ _ S 0724107US
FDA UDI
Class IActive
Ms25 O2 G5/8nl _ _ 9/16 G 0720109US
FDA UDI
Class IActive
Ms6 O2 Pi Ds _ 9/16 S 0720122US
FDA UDI
Class IActive
Mft25 Air Ds _ _9/16 S 0726504US
FDA UDI
Class IActive
Mcn Air Y2 Dsf Dsf G 0731007US
FDA UDI
Class IActive
Vm N2o Cga326 _ _ 9/16 S 0729111US
FDA UDI
Class IActive
Mfu25 _air Ch _ 9/16 G 0728119US
FDA UDI
Class IActive
Ms25 O2 Pi Ds _ 9/16 S 0720111US
FDA UDI
Class IActive

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