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Sign in to claim this brandEvonos GmbH & Co. KG
US
Last updated May 30, 2026
What Evonos GmbH & Co. KG makes
Evonos GmbH & Co. KG manufactures single-use surgical retractors, including blade systems and mounting frames designed for retraction during procedures. Their portfolio also includes an automatic cranial perforator and ENT elevators, which assist in specific surgical applications. These devices are intended for use in operating rooms to improve access and visibility for surgeons.
The company’s products are regulated under FDA pathways, with devices classified as Class I and Class II. They are listed under the 510(k) and UDI programs, indicating compliance with US regulatory requirements. The manufacturer is based in 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 Evonos GmbH & Co. KG manufacture?
Evonos GmbH & Co. KG specializes in single-use surgical devices primarily focused on retraction systems. Their portfolio includes surgical retractor blades, mounting frames for retraction systems, an automatic cranial perforator, and ENT elevators. These devices are designed to assist surgeons by improving access and visibility during procedures, particularly in operating room settings.
Where is Evonos GmbH & Co. KG based?
Evonos GmbH & Co. KG is based in the United States. The company’s location influences its regulatory compliance, particularly under US pathways like the FDA’s 510(k) and UDI programs.
Under which regulatory registries or programs are Evonos GmbH & Co. KG’s devices listed?
Evonos GmbH & Co. KG’s devices are listed under the FDA’s 510(k) premarket notification program and the Unique Device Identifier (UDI) system. These registries ensure compliance with US regulatory requirements for medical devices, helping to track and identify their products in the market.
How are Evonos GmbH & Co. KG’s devices classified under FDA regulations?
Evonos GmbH & Co. KG’s devices fall into two primary FDA classification categories: Class I and Class II. The classification depends on the device’s risk level and intended use—Class I devices generally pose lower risks, while Class II devices require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- evonos.de
- —
- —
- [email protected]
- Phone
- +4974611718959
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 342657915
Catalogue (53)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| evonos | 48-000037 | FDA UDI | Class I | Active |
| evonos | 48-000139 | FDA UDI | Class I | Active |
| evonos | 48-000040 | FDA UDI | Class I | Active |
| evonos | 48-000049 | FDA UDI | Class I | Active |
| evonos | 48-000020 | FDA UDI | Class I | Active |
| evonos | 48-000136 | FDA UDI | Class I | Active |
| Evonos | 26-000004 | FDA UDI | Class II | Active |
| evonos | 48-000115 | FDA UDI | Class I | Active |
| evonos | 48-000118 | FDA UDI | Class I | Active |
| evonos | 48-000120 | FDA UDI | Class I | Active |
| Evonos | 26-414113 | FDA UDI | Class II | Active |
| evonos | 48-000035 | FDA UDI | Class I | Active |
| Evonos | 26-000007 | FDA UDI | Class II | Active |
| evonos | 48-000119 | FDA UDI | Class I | Active |
| Evonos | 26-409063 | FDA UDI | Class II | Active |
| Evonos | 26-411071 | FDA UDI | Class II | Active |
| evonos | 48-000039 | FDA UDI | Class I | Active |
| Evonos | 26-414111 | FDA UDI | Class II | Active |
| evonos | 48-000019 | FDA UDI | Class I | Active |
| evonos | 48-000138 | FDA UDI | Class I | Active |
| evonos | 48-000015 | FDA UDI | Class I | Active |
| evonos | 48-000036 | FDA UDI | Class I | Active |
| Evonos | 26-000009 | FDA UDI | Class II | Active |
| evonos | 48-000045 | FDA UDI | Class I | Active |
| Evonos | 26-411073 | FDA UDI | Class II | Active |
| evonos | 48-000121 | FDA UDI | Class I | Active |
| Evonos | 26-000006 | FDA UDI | Class II | Active |
| evonos | 48-000041 | FDA UDI | Class I | Active |
| evonos | 48-000047 | FDA UDI | Class I | Active |
| Evonos | 26-413091 | FDA UDI | Class II | Active |
| Evonos | 26-000008 | FDA UDI | Class II | Active |
| Evonos | 26-000003 | FDA UDI | Class II | Active |
| evonos | 48-000114 | FDA UDI | Class I | Active |
| Evonos | 26-000002 | FDA UDI | Class II | Active |
| evonos | 48-000002 | FDA UDI | Class I | Active |
| Evonos | 26-000005 | FDA UDI | Class II | Active |
| evonos | 48-000021 | FDA UDI | Class I | Active |
| evonos | 48-000141 | FDA UDI | Class I | Active |
| evonos | 48-000116 | FDA UDI | Class I | Active |
| evonos | 48-000048 | FDA UDI | Class I | Active |
| Evonos | 26-409061 | FDA UDI | Class II | Active |
| evonos | 48-000018 | FDA UDI | Class I | Active |
| evonos | 48-000135 | FDA UDI | Class I | Active |
| evonos | 48-000038 | FDA UDI | Class I | Active |
| evonos | 48-000137 | FDA UDI | Class I | Active |
| evonos | 48-000001 | FDA UDI | Class I | Active |
| evonos | 48-000140 | FDA UDI | Class I | Active |
| evonos | WT405800 | FDA UDI | Class I | Active |
| Evonos | 26-413093 | FDA UDI | Class II | Active |
| evonos | 48-000016 | FDA UDI | Class I | Active |
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