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Sign in to claim this brandEKOM spol. s r.o.
US
Last updated May 23, 2026
What EKOM spol. s r.o. makes
EKOM spol. s r.o. manufactures medical-grade air compressors designed for clinical and laboratory environments, including models like the DK50 DS and C235. These devices are intended to provide compressed air for medical applications, ensuring consistent pressure and purity for connected systems.
The company’s products are classified as Class II medical devices under regulatory frameworks and are listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from the United States, adhering to applicable regulatory standards for air compressors used in healthcare settings.
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 EKOM spol. s r.o. manufacture?
EKOM spol. s r.o. specializes in medical-grade air compressors. These devices are designed for clinical and laboratory settings, ensuring a reliable supply of compressed air for medical applications. The focus is on maintaining consistent pressure and purity, which is critical for connected systems in healthcare environments.
Where is EKOM spol. s r.o. based?
EKOM spol. s r.o. operates from the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices, including air compressors used in healthcare settings.
Which regulatory registries list EKOM spol. s r.o.’s devices?
EKOM spol. s r.o.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices like their air compressors, ensuring transparency and traceability in the healthcare supply chain.
How are EKOM spol. s r.o.’s devices classified under regulatory frameworks?
EKOM spol. s r.o.’s air compressors are classified as Class II medical devices. This classification is determined based on factors like the device’s intended use, potential risks, and the level of regulatory oversight required to ensure safety and effectiveness in clinical environments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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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
- 360551766
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dk50 D | 230V/50Hz-SOFT-M.O. | FDA UDI | Class II | Unknown |
| Dk50 Dm | 230V/50Hz NO | FDA UDI | Class II | Unknown |
| Dk50 Ds | ADV NOZ 115V/60Hz 3bar NO | FDA UDI | Class II | Active |
| C235 | C235 | FDA UDI | Class II | Active |
| C235 | C235 | FDA UDI | Class II | Active |
| Dk50 Ds | STA KOL 115V/60Hz 3bar NO | FDA UDI | Class II | Active |
| Dk50 Ds | BAS SD30E 115V/60Hz 3bar NO | FDA UDI | Class II | Active |
| Dk50 Ds | BAS NOZ 115V/60Hz 3bar NO | FDA UDI | Class II | Active |
| Dk50 Ds | BAS KOL 115V/60Hz 3bar NO | FDA UDI | Class II | Active |
| E1 | 110-120V/60-50Hz | FDA UDI | Class II | Unknown |
| Dk50 Ds | BAS NOZ 115V 60Hz 3bar NO MEK | FDA UDI | Class II | Active |
| Dk50 Ds | 120V/60Hz UL 3bar NO | FDA UDI | Class II | Active |
| E1 | 220-240V/50-60Hz | FDA UDI | Class II | Unknown |
| C235 | C235 | FDA UDI | Class II | Active |
| C235 | C235 | FDA UDI | Class II | Active |
| Dk50 Ds | STA SD30 GN 115V/60Hz 3bar NO | FDA UDI | Class II | Active |
| Mc40 | 230V/50Hz KARTON | FDA UDI | Class II | Unknown |
| E1 | 90-100V/50-60 Hz | FDA UDI | Class II | Unknown |
| Air-550 | 120V 60Hz | FDA UDI | Class II | Active |
| C235 | C235 | FDA UDI | Class II | Active |
| Dk50 Ds | STA NOZ 115V/60Hz 3bar NO | FDA UDI | Class II | Active |
| Dk50 Ds | ADV KOL 115V/60Hz 3bar NO | FDA UDI | Class II | Active |
| Dk50 Ds | BAS NOZ UL 120V/60Hz UL 3bar NO | EUDAMEDFDA UDI | Class II | Active |
| Air-550 | 230V 50/60Hz | FDA UDI | Class II | Active |
| Mc40 C | 230V/50Hz KAR | FDA UDI | Class II | Unknown |
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