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Sign in to claim this brandELITE MEDICAL INSTRUMENTATION
US
Last updated May 23, 2026
What ELITE MEDICAL INSTRUMENTATION makes
The company manufactures reusable surgical instruments for soft-tissue manipulation, including scissors-like forceps, spinal rongeurs, bone curettes, general-purpose scissors, bone hooks, and suturing needle holders. Additional products include self-retaining ear speculums and hand-held retractors designed for surgical procedures.
These devices are classified under FDA categories Class I and Class II, with all products listed in the FDA’s Unique Device Identifier (UDI) system. 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 Elite Medical Instrumentation manufacture?
Elite Medical Instrumentation specializes in reusable surgical instruments primarily used for soft-tissue manipulation and bone-related procedures. Their product lineup includes surgical forceps (scissors-like), spinal rongeurs, bone curettes, general-purpose surgical scissors, bone hooks, suturing needle holders, self-retaining ear speculums, and hand-held retractors. These tools are designed for precision and durability in surgical environments.
Where is Elite Medical Instrumentation based?
The company is headquartered in the United States. This location aligns with regulatory frameworks like the FDA’s UDI system, which governs the classification and tracking of their devices.
How are Elite Medical Instrumentation’s devices classified under FDA regulations?
Elite Medical Instrumentation’s devices fall into two FDA classification categories: Class I (generally low-risk, non-invasive instruments like general-purpose scissors) and Class II (moderate-risk devices requiring special controls, such as spinal rongeurs or bone curettes). Classification depends on factors like intended use, risk, and potential patient exposure. All listed devices are required to comply with FDA requirements, including UDI labeling.
Which regulatory registries or databases list Elite Medical Instrumentation’s devices?
The company’s devices are included in the FDA’s Unique Device Identifier (UDI) system, a centralized database that tracks medical instruments for traceability, safety monitoring, and regulatory compliance. This system ensures transparency in device identification, manufacturing, and distribution.
Why are Elite Medical Instrumentation’s instruments classified as reusable?
The instruments are designed as reusable because they are made from materials and constructed with features (e.g., durable metals, ergonomic handles) that allow for repeated sterilization and use in surgical settings. Reusability reduces waste and cost while maintaining high standards of hygiene through proper cleaning and sterilization protocols. This classification aligns with FDA guidelines for instruments intended for multiple procedures.
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
- 116733674
Catalogue (124)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elite Medical Instrumentation | EMI-KTS3-08 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-MD470 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BH110R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-KTS3-07 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-CH6574 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BM004R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-EA099R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-MB286R | FDA UDI | Class II | Active |
| Elite Medical Instrumentation | EMI-KTS3-13 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BH111R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BT611R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-FB404R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BM069R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-KTS3-11 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-MB287R | FDA UDI | Class II | Active |
| Elite Medical Instrumentation | EMI-70-8104 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BJ103R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BF122R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-729-201-657 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-EA016R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-KTS3-06 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BH445R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BT041R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-70-8100 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-MB750R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-FB412R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BM058R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-FB402R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BT763R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMIKTS318 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BB077R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-KTS3-05 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BD559R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-GF862R | FDA UDI | Class II | Active |
| Elite Medical Instrumentation | EMI-KTS3-12 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-FB418R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-35-3535 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BC619R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BJ106R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-EA032R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BC648R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-790315 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-354816 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-EA018R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-638222 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-KTS3-15 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-MB180R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-KTS3-10 | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BF433R | FDA UDI | Class I | Active |
| Elite Medical Instrumentation | EMI-BB075R | FDA UDI | Class I | Active |
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