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Sign in to claim this brandELMED INCORPORATED
US
Last updated May 24, 2026
What ELMED INCORPORATED makes
Elmed Incorporated manufactures reusable surgical instruments, including rigid endoscopic forceps for tissue manipulation, laparoscopes, and laparoscopic surgical procedure kits. Their portfolio also covers reusable hand-held retractors, bipolar and monopolar electrosurgical handpieces and electrodes for open-surgery, as well as non-medicated ENT and arthroscopic surgical procedure kits.
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. Elmed Incorporated 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 Elmed Incorporated manufacture?
Elmed Incorporated specializes in reusable surgical instruments, including rigid endoscopic tissue manipulation forceps, laparoscopes, and laparoscopic surgical procedure kits. Their product range also includes reusable hand-held retractors, bipolar and monopolar electrosurgical handpieces/electrodes for open-surgery, as well as non-medicated ENT and arthroscopic surgical procedure kits. These devices are designed for various surgical applications, from minimally invasive procedures to open surgeries.
Where is Elmed Incorporated based?
Elmed Incorporated is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, particularly for FDA-related processes.
Which regulatory registries list Elmed Incorporated’s devices?
Elmed Incorporated’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 in regulatory and clinical settings.
How are Elmed Incorporated’s devices classified under FDA regulations?
Elmed Incorporated’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may require less regulatory oversight, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and requirements for each device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- elmed.com
- —
- —
- [email protected]
- Phone
- 224-353-6446
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 049290364
Catalogue (12842)
Page 257 of 257| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elmed | 52450-03-H | FDA UDI | Class I | Active |
| Elmed | 5-0545-68B | FDA UDI | Class II | Active |
| Elmed | 52265-51C | FDA UDI | Class II | Active |
| Elmed | 5-0545-135B | FDA UDI | Class II | Active |
| Elmed Incorporated | ST5243002H | FDA UDI | Class I | Active |
| Elmed | 37621-110 | FDA UDI | Class I | Active |
| Elmed | ST2302016 | FDA UDI | Class I | Active |
| Elmed | ST248100 | FDA UDI | Class I | Active |
| Elmed | 31-9350-08 | FDA UDI | Class I | Active |
| Elmed | 5-0524-20A | FDA UDI | Class II | Active |
| Elmed | 52224-26A | FDA UDI | Class II | Active |
| Elmed | 5983-07 | FDA UDI | Class II | Active |
| Elmed | 52430-03 | FDA UDI | Class I | Active |
| Elmed | 52105-30 | FDA UDI | Class II | Active |
| Elmed Incorporated | 5213-10A | FDA UDI | Class II | Active |
| Elmed | ST240723 | FDA UDI | Class I | Active |
| Elmed | 24-3785-137 | FDA UDI | Class I | Active |
| Elmed | ST202413TC | FDA UDI | Class I | Active |
| Elmed | 13-60799279B | FDA UDI | Class I | Active |
| Elmed | 37378-03 | FDA UDI | Class I | Active |
| Elmed | 18-3724-I | FDA UDI | Class I | Active |
| Elmed | ST13906501 | FDA UDI | Class I | Active |
| Elmed | 18-3788 | FDA UDI | Class I | Active |
| Elmed | 52224-116A | FDA UDI | Class II | Active |
| Elmed Incorporated | ST153503I | FDA UDI | Class I | Active |
| Elmed Incorporated | ST321205I | FDA UDI | Class I | Active |
| Elmed Incorporated | 55965-14 | FDA UDI | Class I | Active |
| Elmed Incorporated | 52505-65I | FDA UDI | Class II | Active |
| Elmed Incorporated | 32-18-01-I | FDA UDI | Class I | Active |
| Elmed Incorporated | 52502-53 | FDA UDI | Class II | Active |
| Elmed Incorporated | ST5586 | FDA UDI | Class II | Active |
| Elmed | 52255-426A | FDA UDI | Class II | Active |
| Elmed | 52265-24C | FDA UDI | Class II | Active |
| Elmed | 5806-15 | FDA UDI | Class II | Active |
| Elmed | 52155-144C | FDA UDI | Class II | Active |
| Elmed | 5-0533-67A | FDA UDI | Class II | Active |
| Elmed Incorporated | ST155319E | FDA UDI | Class I | Active |
| Elmed Incorporated | ST5250586P | FDA UDI | Class II | Active |
| Elmed | 5511-08 | FDA UDI | Class II | Active |
| Elmed | 52101-48C | FDA UDI | Class II | Active |
| Elmed 00198506083532 | 20-41174 | FDA UDI | Class I | Active |
| ELMED Laparoscopic Instruments and Accessories | K181173 | FDA 510(k) | Class II | Active |
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