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Sign in to claim this brandZUTRON MEDICAL, L.L.C.
US
Last updated May 27, 2026
What ZUTRON MEDICAL, L.L.C. makes
Zutron Medical, LLC produces electrical invasive medical device leak testers, designed to verify the integrity of sealed medical devices by detecting leaks in their electrical components.
The company’s products are classified as Class I devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database.
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 Zutron Medical, LLC manufacture?
Zutron Medical, LLC specializes in electrical invasive medical device leak testers. These devices are specifically designed to test the integrity of sealed medical devices by identifying leaks in their electrical components, ensuring they meet safety and performance standards before use.
Where is Zutron Medical, LLC based?
Zutron Medical, LLC is headquartered in the United States. The company’s focus is on developing and manufacturing its core product line within this region.
How are Zutron Medical, LLC’s devices classified under FDA regulations?
Zutron Medical, LLC’s devices fall under Class I classification according to FDA regulations. This classification is typically assigned to devices posing minimal risk to patients, such as those used for testing rather than direct patient treatment. The classification is determined based on factors like the device’s purpose, intended use, and potential risks.
Are Zutron Medical, LLC’s devices listed in any regulatory databases?
Yes, Zutron Medical, LLC’s devices are included 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 compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- 8773435873
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 962532441
Catalogue (99)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endo Leak Tester | FDA UDI | Class I | Unknown |
| Zutron Medical | ZUTR162000 | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endo Leak Tester | FDA UDI | Class I | Unknown |
| Zutron Medical | Endo Leak Tester | FDA UDI | Class I | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endo Leak Tester | FDA UDI | Class I | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | ZUTR161700 | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | N/A | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
| Zutron Medical | Endoscopy Procedure Kit | FDA UDI | Class II | Unknown |
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