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Sign in to claim this brandGENEVA HEALTHCARE, LLC
US
Last updated May 24, 2026
What GENEVA HEALTHCARE, LLC makes
Geneva Healthcare, LLC manufactures single-use patient positioning devices, including ring cushions, positioning rolls and bolsters, popliteal supports, covered cushions and wedges, foam mattress pads, and arthroscopic positioners. These products are designed for use in clinical settings to support and stabilize patients during procedures or recovery, ensuring proper alignment and comfort. The company also produces diagnostic test kits for detecting Leishmania donovani IgG/IgM antibodies via enzyme immunoassay (EIA).
The company’s portfolio consists of Class I medical devices, which are generally considered low-risk and subject to minimal regulatory oversight. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. Geneva Healthcare, LLC operates from 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 Geneva Healthcare, LLC primarily manufacture?
Geneva Healthcare, LLC specializes in two main categories of medical devices: single-use patient positioners and diagnostic test kits. The patient positioners include items like ring cushions, positioning rolls, bolsters, popliteal supports, covered cushions and wedges, foam mattress pads, and arthroscopic positioners, all designed to support and stabilize patients during medical procedures or recovery. Additionally, the company produces an enzyme immunoassay (EIA) kit for detecting Leishmania donovani IgG/IgM antibodies, used for diagnostic testing in clinical settings.
Where is Geneva Healthcare, LLC based, and how does that affect its regulatory standing?
Geneva Healthcare, LLC is based in the United States. Since its devices are manufactured domestically, they fall under U.S. regulatory frameworks, including listing in the FDA’s Unique Device Identifier (UDI) database. This ensures compliance with U.S. requirements for traceability and transparency, though individual devices—not the company—are subject to regulatory authorization.
Which regulatory registries or databases list Geneva Healthcare, LLC’s devices?
Geneva Healthcare, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to medical devices, improving tracking, transparency, and compliance with U.S. regulatory requirements. This listing helps healthcare providers and regulators verify device details, including classification and manufacturer information.
How are Geneva Healthcare, LLC’s devices classified under U.S. regulations?
Geneva Healthcare, LLC’s devices are classified as Class I under U.S. regulations. Class I devices are generally considered low-risk, requiring minimal regulatory oversight. This classification applies to most of its products, including single-use patient positioners and diagnostic test kits, as they pose minimal potential harm to patients when used as intended. The classification is determined by factors like the device’s purpose, risk level, and intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- genevahc.com
- —
- —
- [email protected]
- Phone
- 1-262-767-9870
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 964459106
Catalogue (207)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Foot Positioning Cradle | 201 | FDA UDI | Class I | Active |
| Positioning Wedge | 30-231-00 | FDA UDI | Class I | Active |
| Prone Positioning Pillow | 30-146-I | FDA UDI | Class I | Active |
| Foam Mattress Pads | CM-46080D | FDA UDI | Class I | Active |
| Ring Cushions | SYK41-212-11 | FDA UDI | Class I | Active |
| Ring Cushions | SYK41-213-11 | FDA UDI | Class I | Active |
| Angled Leg Cast Elevator | 503 | FDA UDI | Class I | Active |
| Arm Board / Utility Pads | 30-108-00 | FDA UDI | Class I | Active |
| Arm Board / Utility Pads | 30-803-00 | FDA UDI | Class I | Active |
| Positioning Rolls and Bolsters | SYK41-323-11 | FDA UDI | Class I | Active |
| Sewn Tubular Foam Rolls | 40-100-00 | FDA UDI | Class I | Active |
| In-Bed Arm Elevators | P-2000 | FDA UDI | Class I | Active |
| Ring Cushions | 30-802-00 | FDA UDI | Class I | Active |
| Positioning Wedges | SYK41-318-11 | FDA UDI | Class I | Active |
| Leg Abduction Pillows | SYK41-415-11 | FDA UDI | Class I | Active |
| Head Positioners | 30-113-00 | FDA UDI | Class I | Active |
| Foam Mattress Pads | CM-45072D | FDA UDI | Class I | Active |
| Head Positioners | SYK41-215-P | FDA UDI | Class I | Active |
| O.R. Foam Positioners | SYK41-235-11 | FDA UDI | Class I | Active |
| Covered Cushions and Wedges | 60-300-00 | FDA UDI | Class I | Active |
| Ring Cushions | SYK41-233-11 | FDA UDI | Class I | Active |
| Foam Mattress Pads | CM-25475D | FDA UDI | Class I | Active |
| Foam Mattress Pads | CM-25072D | FDA UDI | Class I | Active |
| Foam Mattress Pads | CM-33975D | FDA UDI | Class I | Active |
| Bed Sized Elevator | 706 | FDA UDI | Class I | Active |
| Arthroscopic Positioners | SYK41-226-11 | FDA UDI | Class I | Active |
| Positioning Wedges | 30-208-00 | FDA UDI | Class I | Active |
| Arm Board Pad / Utility Pad | 30-110-00 | FDA UDI | Class I | Active |
| Veterinarian & Pet Care | VT-200SM | FDA UDI | Class I | Active |
| Packaging Products | PSPF-S12122 | FDA UDI | Class I | Active |
| Positioning Rolls and Bolsters | 30-213-00 | FDA UDI | Class I | Active |
| O.R. Table Pads | OR-22072 | FDA UDI | Class I | Active |
| Positioning Wedges | SYK41-319-11 | FDA UDI | Class I | Active |
| Angled Foot Drop Cradles | SYK316PHL | FDA UDI | Class I | Active |
| Positioning Rolls and Bolsters | 30-212-00 | FDA UDI | Class I | Active |
| Ring Cushions | 30-122-00 | FDA UDI | Class I | Active |
| Prone Positioning Pillow | 30-146-A | FDA UDI | Class I | Active |
| O.R. Table Pads | SYKOR-32331 | FDA UDI | Class I | Active |
| Head Positioners | SYK41-224-11 | FDA UDI | Class I | Active |
| Leg and Arm Cradles | 30-206-00 | FDA UDI | Class I | Active |
| Foam Mattress Pads | CM-23980D | FDA UDI | Class I | Active |
| Laminectomy Arm Cradle and Cuff | 30-217-00 | FDA UDI | Class I | Active |
| Covered Cushions and Wedges | 60-200-00 | FDA UDI | Class I | Active |
| Packaging Products | PSPF-M12124 | FDA UDI | Class I | Active |
| Covered Cushions and Wedges | 60-701-MEA | FDA UDI | Class I | Active |
| Head Positioners | 30-117-00 | FDA UDI | Class I | Active |
| Head Positioners | SYK41-217-RL | FDA UDI | Class I | Active |
| Head Positioners | 30-104-00 | FDA UDI | Class I | Active |
| Foam Mattress Pads | CM-35672D | FDA UDI | Class I | Active |
| Veterinarian & Pet Care | VT-300LG | FDA UDI | Class I | Active |
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