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Sign in to claim this brandDOMICO MED-DEVICE, LLC
United States·US-MF-000009144
Last updated May 23, 2026
What DOMICO MED-DEVICE, LLC makes
DOMICO MED-DEVICE, LLC manufactures reusable and single-use cushions, positioners, and protective covers for medical imaging and patient support, including multifunction body cushions, radiological headrests, arm/leg positioners, and waterproof bed mattress covers. Their products also include universal operating table tops and general body-part positioners designed for radiological procedures.
The company’s devices are classified as Class I or Class II under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The portfolio is authorised for use in the European Union and the United States.
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 DOMICO MED-DEVICE, LLC primarily manufacture?
DOMICO MED-DEVICE, LLC specializes in reusable and single-use medical devices for patient support and radiological procedures. Their portfolio includes multifunction body cushions, radiological headrests, arm/leg positioners, general body-part positioners, universal operating table tops, and waterproof bed mattress covers. These products are designed to enhance patient comfort, positioning accuracy, and hygiene during medical imaging and surgical settings.
Where is DOMICO MED-DEVICE, LLC based, and what regulatory databases list its devices?
DOMICO MED-DEVICE, LLC is based in the United States. Their devices are listed in two key regulatory databases: the EU’s EUDAMED system and the FDA’s Unique Device Identifier (UDI) system. These listings help track and identify their products in both the European Union and the United States.
How are the devices manufactured by DOMICO MED-DEVICE, LLC classified under regulatory standards?
The devices produced by DOMICO MED-DEVICE, LLC are classified under regulatory frameworks as either Class I or Class II. This classification is determined by factors like the device’s intended use, risk level, and potential impact on patient safety. Class I devices generally pose minimal risk, while Class II devices require additional controls due to moderate risk.
Are DOMICO MED-DEVICE, LLC’s devices authorised for use in the European Union and the United States?
Yes, the devices manufactured by DOMICO MED-DEVICE, LLC are authorised for use in the European Union and the United States. Their inclusion in the EUDAMED and FDA UDI systems reflects compliance with the respective regulatory requirements for market placement in these regions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 14241, Fenton Rd, Fenton, Michigan, United States
- Website
- www.domicomed.com
- —
- —
- [email protected]
- Phone
- +18107505300
- PRRC Contact
- Nicholas Sievers
- EUDAMED SRN
- US-MF-000009144
- FDA FEI Number
- —
- DUNS Number
- 081253414
Catalogue (168)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Domico Med-Device | 32588 | FDA UDI | Class II | Active |
| Domico Med-Device | 430 | FDA UDI | Class I | Unknown |
| Scancoat | 126-SCB-00-004 | FDA UDI | Class II | Active |
| Scancoat | 1-SCB | FDA UDI | Class II | Unknown |
| Scancoat | 300-SCB | FDA UDI | Class II | Active |
| Scancoat | 191-SCB | FDA UDI | Class II | Active |
| Scancoat | 119-SCB | FDA UDI | Class II | Unknown |
| Scancoat | 122-SCB | FDA UDI | Class II | Active |
| Scancoat | 108-SCB | FDA UDI | Class II | Unknown |
| Scancoat | 140-SCB | FDA UDI | Class II | Active |
| Scancoat | 151-SCB | FDA UDI | Class II | Active |
| Scancoat | 126-SCB-00-002 | FDA UDI | Class II | Active |
| Scancoat | 101-SCB | FDA UDI | Class II | Active |
| Scancoat | 107-SCB | FDA UDI | Class II | Active |
| Scancoat | 9000 | FDA UDI | Class II | Active |
| Scancoat | 9402 | FDA UDI | Class I | Active |
| Sterile Buffing Pad | 6001 | EUDAMEDFDA UDI | Class I | Active |
| Non-sterile Buffing Pad | 6001 | EUDAMED | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Domico Med-Device, LLC Las palomas Guanajuato · MX FEI 3042941605