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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 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
MediVitop MT25 O2 3/4UNF CGA540 DS S
FDA UDI
Class IActive
Mtc25 O2 Cga540 Ds _ 9/16 G 0721103US
FDA UDI
Class IActive
Mcn Vac W1 Dsf Dsf S 0731021US
FDA UDI
Class IActive
Mcn O2 G1 Dsf Ds G 0731002US
FDA UDI
Class IActive
Mtc25 O2 Pi Ds _ 916 0721101US
FDA UDI
Class IActive
Mfu15 _air Ch _ 9/16 G 0728118US
FDA UDI
Class IActive
Mcn Air Y1 Dsf Dsf S 0731017US
FDA UDI
Class IActive
Mtc6 O2 Pi Ds _ 9/16 G 0721102US
FDA UDI
Class IActive
MS25 O2 PI 2xDISS 9/16 G 0720127US
FDA UDI
Class IActive
Mcn O2 G2 Dsf Ds G 0731004US
FDA UDI
Class IActive
Vm Air Pi _ _ 9/16 G 0729119US
FDA UDI
Class IUnknown
Me+250 _ Ds _ G1/2 S 0735106US
FDA UDI
Class IIActive
Mm15 Dy O2 Ds _ 9/16 S 0730110US
FDA UDI
Class IActive
Ms25 O2 Cga540 Ds _ 9/16 S 0720113US
FDA UDI
Class IActive
Varimed+ VM+ AIR CGA346 DS _ _ S
FDA UDI
Class IActive
Mfu15 _air Ds _ 9/16 G 0728115US
FDA UDI
Class IActive
Me+1000 _ Ds _ G1/2 G 0735101US
FDA UDI
Class IIActive
Varimed+ VM+ N2O PI DS _ _ S
FDA UDI
Class IActive
Vm Air Cga346 _ _ 9/16 G 0729104US
FDA UDI
Class IActive
Mr Air_pi_ds _ _ G 0724109US
FDA UDI
Class IUnknown
Mr O2 Cga540 Ds _ _ S 0724106US
FDA UDI
Class IActive
Ms25 Air Cga346 Ds _ 9/16 S 0720115US
FDA UDI
Class IActive
Varimed VM AIR CGA346 _ _ 9/16 S
FDA UDI
Class IActive
Mm60 _o2 Ds _ 9/16unf S 0730114US
FDA UDI
Class IActive
Vm N2o Cga326 _ _ 9/16 G 0729105US
FDA UDI
Class IActive
Mfu15 _ O2 Ds _ 9/16 G 0728108US
FDA UDI
Class IActive
Gce, 40-120 Psi, _, _, Hn, Green, C 0728101US
FDA UDI
Class IUnknown
Mcn O2 G1 Dsf Dsf S 0731013US
FDA UDI
Class IActive
Mfu25 _ Air Ds _ 9/16 G 0728102US
FDA UDI
Class IActive
Me+1000 _ Ds _ G1/2 S 0735104US
FDA UDI
Class IIActive
Mfu25 _air Ds _ 9/16 S 0728105US
FDA UDI
Class IActive
Ms6 O2 Cga540 Ds _ 9/16 S 0720114US
FDA UDI
Class IActive
Ms25 O2 G5/8nl Dn _ 9/16 G 0720110US
FDA UDI
Class IActive
Mtc6 O2 Cga540 Ds _ 9/16 S 0721110US
FDA UDI
Class IActive
Ms25 O2 Pi Dn _ 9/16 G 0720108US
FDA UDI
Class IActive
Mtc6 O2 Cga540 Ds _ 9/16 G 0721104US
FDA UDI
Class IActive
Vm O2 Cga870 _ _ 9/16 S 0729108US
FDA UDI
Class IUnknown
Mcn Vac W2 Dsf Ds G 0731012US
FDA UDI
Class IActive
Mcn Vac W2 Dsf Dsf S 0731023US
FDA UDI
Class IActive
Ms25 O2 Pi Dn _ 9/16 S 0720118US
FDA UDI
Class IActive
Mft 25 _ Air Ds _ 9/16 G 0726502US
FDA UDI
Class IActive
Me+600 _ Ds _ G1/2 S 0735105US
FDA UDI
Class IIActive
Ms6 O2 Pi Ds _ 9/16 S 0720112US
FDA UDI
Class IActive
Ms6 Air Cga346 Ds _ 9/16 G 0720106US
FDA UDI
Class IActive
Vm O2 Cga540 _ _ 9/16 G 0729100US
FDA UDI
Class IActive
MediMeter MM60 _O2 DS _ 9/16UNF G
FDA UDI
Class IUnknown
Mm15 Dy Air Ds _ 9/16 S 0730112US
FDA UDI
Class IActive
Ms25 O2 Pi Dn _ 9/16 S 0720126US
FDA UDI
Class IActive
Vm O2 Cga540 _ _ 9/16 S 0729106US
FDA UDI
Class IActive
Mcn Air Y2 Dsf Ds S 0731020US
FDA UDI
Class IActive

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