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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 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
Ms25 O2 G5/8nl _ _ 9/16 S 0720119US
FDA UDI
Class IActive
Mr15f O2 Cga540_ _ 9/16 S 0724108US
FDA UDI
Class IActive
Mcn Vac W1 Dsf Ds S 0731022US
FDA UDI
Class IActive
Ms25 O2 G5/8nl Dn _ 9/16 S 0720120US
FDA UDI
Class IActive
Ms25 Air Cga346 Ds _ 9/16 G 0720105US
FDA UDI
Class IActive
Varimed+ VM+ CO2 CGA320 DS _ _ S
FDA UDI
Class IActive
Vm+ O2 Cga540 _ _ 9/16 S 0729107US
FDA UDI
Class IActive
Mcn Vac W2 Dsf Dsf G 0731011US
FDA UDI
Class IActive
Mfu15 _ O2 Ch _ 9/16 G 0728113US
FDA UDI
Class IActive
Me+250 _ Ds _ G1/2 G 0735103US
FDA UDI
Class IIActive
Ms25 O2 Pi Ds _ 9/16 S 0720121US
FDA UDI
Class IActive
Ms25 O2 Pi Ds _ 9/16 G 0720101US
FDA UDI
Class IActive
Mm15 _o2 Ds _ 9/16unf G 0730101US
FDA UDI
Class IActive
Mft 25 _ O2 Ds _9/16 G 0726501US
FDA UDI
Class IActive
Varimed+ VM+ AIR PI DS _ _ S
FDA UDI
Class IActive
Mm15 Dy Air Ds _ 9/16 G 0730105US
FDA UDI
Class IActive
MS25 O2 PI 2xDISS 9/16 S 0720128US
FDA UDI
Class IActive
Mcn Air Y1 Dsf Ds S 0731018US
FDA UDI
Class IActive
Varimed VM CO2 CGA320 DS _ _ S
FDA UDI
Class IActive
MediMeter MM30 _O2 DS _ 9/16UNF G
FDA UDI
Class IUnknown
Mfu2 _ O2 Oh _ 9/16 G 0728109US
FDA UDI
Class IActive
Vm+ O2 Cga870 _ _ 9/16 G 0729103US
FDA UDI
Class IActive
Mfu25 _ O2 Ds _ 9/16 G 0728101US
FDA UDI
Class IActive
Mcn Vac W1 Dsf Dsf G 0731009US
FDA UDI
Class IActive
Mr O2 Cga540 Ds _ _ S 0724105US
FDA UDI
Class IActive
Mm15 _o2 Ds _ 9/16unf S 0730108US
FDA UDI
Class IActive
Varimed VM O2 CGA870 _ _ 9/16 S
FDA UDI
Class IActive
Ms6 O2 Cga540 Ds _ 9/16 S 0720124US
FDA UDI
Class IActive
MediConnect MCN AIR Y2 DSF DSF S
EUDAMEDFDA UDI
Class IActive
Mtc25 O2 Pi Ds _ 916 S 0721107US
FDA UDI
Class IActive
Vm Air Cga346 _ _ 9/16 S 0729110US
FDA UDI
Class IActive
Ms6 Air Cga346 Ds _ 9/16 S 0720116US
FDA UDI
Class IActive
Mfu25 _ O2 Oh _ 9/16 G 0728111US
FDA UDI
Class IActive
Mm30 _o2 Ds _ 9/16unf S 0730113US
FDA UDI
Class IActive
Mcn O2 G2 Dsf Ds S 0731016US
FDA UDI
Class IActive
Mm15 _ Air Ds _ 9/16unf S 0730111US
FDA UDI
Class IActive
Mcn O2 G1 Dsf Ds S 0731014US
FDA UDI
Class IActive
Mfu25 _air Oh _ 9/16 G 0728117US
FDA UDI
Class IActive
Vm O2 Cga870 _ _ 9/16 G 0729102US
FDA UDI
Class IActive
Mfu25 _ O2 Ds _ 9/16 S 0728104US
FDA UDI
Class IActive
Mtc6 Air Cga346 Ds _ 9/16 S 0721112US
FDA UDI
Class IActive
Mtc25 Air Cga346 Ds _ 9/16 G 0721105US
FDA UDI
Class IActive
Varimed VM O2 CGA540 _ PTBH 9/16 G
FDA UDI
Class IActive
Mfu25 _ O2 Ch _ 9/16 G 0728114US
FDA UDI
Class IActive
Mcn Vac W2 Dsf Ds S 0731024US
FDA UDI
Class IActive
Ms25 O2 Pi _ _ 9/16 S 0720125US
FDA UDI
Class IActive
Mr O2 Pi Ds _ _ G 0724101US
FDA UDI
Class IActive
Mm15 _ Air Ds _ 9/16unf G 0730104US
FDA UDI
Class IActive

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