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Sign in to claim this brandENTERIX INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 236 Fernwood Ave, EDISON, NJ, 08837
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- 18005313681
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003224146
- DUNS Number
- 002224009
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| InSure FIT | 01 | FDA UDI | Class II | Active |
| InSure® ONE™ | 01 | FDA UDI | Class II | Active |
| InSure® ONE™ | 01 | FDA UDI | Class II | Active |
| InSure® ONE™ | 01 | FDA UDI | Class II | Active |
| InSure FIT | 01 | FDA UDI | Class II | Active |
| InSure® ONE™ | 01 | FDA UDI | Class II | Active |
| InSure FIT | 01 | FDA UDI | Class II | Active |
| InSure® ONE™ | 01 | FDA UDI | Class II | Active |
| InSure FIT | 01 | FDA UDI | Class II | Active |
| InSure FIT | 01 | FDA UDI | Class II | Active |
| InSure FIT | 01 | FDA UDI | Class II | Active |
| InSure FIT | 01 | FDA UDI | Class II | Active |
| InSure® ONE™ | 01 | FDA UDI | Class II | Active |
| InSure FIT | 01 | FDA UDI | Class II | Active |
| InSure® ONE™ | 01 | FDA UDI | Class II | Active |
| InSure® ONE™ | 01 | FDA UDI | Class II | Active |
| InSure ONE | K170548 | FDA 510(k) | Class II | Active |
| !nsure Fecal Occult Blood Test | K002457 | FDA 510(k) | Class II | Active |
| Insure Ii | K060930 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 17, 2025 | Z-0725-2026 | — | open, classified | InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. |
| Oct 8, 2020 | Z-0590-2021 | — | terminated | Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy |
| Oct 3, 2008 | Z-0480-2009 | — | terminated | False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. For further information, please contact Enterix, Inc. at 1-800-531--3681. |