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Sign in to claim this brandAztecmed/Ent LLC
US
Last updated May 30, 2026
What Aztecmed/Ent LLC makes
The company manufactures reusable surgical instruments, including soft-tissue manipulation forceps (both tweezers-like and alligator styles), general-purpose surgical scissors, illuminating irrigation/aspiration cannulas, open-surgery biopsy forceps, general-purpose curettes, and suturing needle holders. It also produces reusable ear speculums designed for clinical examination.
All listed devices fall under Class I regulatory classification in the U.S. and are registered in the FDA’s Unique Device Identifier (UDI) database. The company 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 Aztecmed/Ent LLC manufacture?
Aztecmed/Ent LLC specializes in reusable surgical instruments. Their product range includes surgical forceps for soft-tissue manipulation (such as tweezers-like and alligator styles), general-purpose surgical scissors, illuminating irrigation/aspiration cannulas, reusable open-surgery biopsy forceps, general-purpose curettes, suturing needle holders, and reusable ear speculums for clinical examinations. These devices are designed for use in surgical and procedural settings.
Where is Aztecmed/Ent LLC based?
Aztecmed/Ent LLC is based in the United States. The company’s headquarters and manufacturing operations are located within the country, though specific regional details are not provided.
Which regulatory registries list Aztecmed/Ent LLC’s devices?
Aztecmed/Ent LLC’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices, which are typically low-risk surgical instruments. The UDI system helps healthcare providers and regulators identify and track specific devices.
How are Aztecmed/Ent LLC’s devices classified under U.S. regulations?
All of Aztecmed/Ent LLC’s listed devices fall under Class I regulatory classification in the U.S. This classification applies to low-risk surgical instruments, such as reusable forceps, scissors, and speculums, which generally pose minimal risk to patients when used as intended. Class I devices typically require only general controls (e.g., good manufacturing practices) rather than pre-market approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- aztecmed.com
- —
- —
- [email protected]
- Phone
- 800-223-3859
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 117559084
Catalogue (189)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aztec | 10-22105 | FDA UDI | Class I | Active |
| Aztec | 10-10012 | FDA UDI | Class I | Active |
| Aztec | 11-15300 | FDA UDI | Class I | Active |
| Aztec | 10-14404 | FDA UDI | Class I | Active |
| Aztec | 10-29111 | FDA UDI | Class I | Active |
| Aztec | 10-21015 | FDA UDI | Class I | Active |
| Aztec | 10-12500 | FDA UDI | Class I | Active |
| Aztec | 10-11023 | FDA UDI | Class I | Active |
| Aztec | 10-12200 | FDA UDI | Class I | Active |
| Aztec | 10-26510 | FDA UDI | Class I | Active |
| Aztec | 10-15303 | FDA UDI | Class I | Active |
| Aztec | 11-30010 | FDA UDI | Class I | Active |
| Aztec | 10-15311 | FDA UDI | Class I | Active |
| Aztec | 10-14012 | FDA UDI | Class I | Active |
| Aztec | 10-18100 | FDA UDI | Class I | Active |
| Aztec | 10-15708 | FDA UDI | Class I | Active |
| Aztec | 10-22101 | FDA UDI | Class I | Active |
| Aztec | 11-24610 | FDA UDI | Class I | Active |
| Aztec | 11-15612 | FDA UDI | Class I | Active |
| Aztec | 11-30011 | FDA UDI | Class I | Active |
| Aztec | 11-15703 | FDA UDI | Class I | Active |
| Aztec | 10-12302 | FDA UDI | Class I | Active |
| Aztec | 11-15305 | FDA UDI | Class I | Active |
| Aztec | 10-12102 | FDA UDI | Class I | Active |
| Aztec | 10-21012 | FDA UDI | Class I | Active |
| Aztec | 10-15610 | FDA UDI | Class I | Active |
| Aztec | 10-29119 | FDA UDI | Class I | Active |
| Aztec | 10-14430 | FDA UDI | Class I | Active |
| Aztec | 10-16371 | FDA UDI | Class I | Active |
| Aztec | 10-16370 | FDA UDI | Class I | Active |
| Aztec | 10-15492 | FDA UDI | Class I | Active |
| Aztec | 10-16203 | FDA UDI | Class I | Active |
| Aztec | 11-24200 | FDA UDI | Class I | Active |
| Aztec | 10-17900 | FDA UDI | Class I | Active |
| Aztec | 10-18013 | FDA UDI | Class I | Active |
| Aztec | 10-14011 | FDA UDI | Class I | Active |
| Aztec | 10-18012 | FDA UDI | Class I | Active |
| Aztec | 10-22104 | FDA UDI | Class I | Active |
| Aztec | 11-30008 | FDA UDI | Class I | Active |
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