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Dental unit Model: Mare
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K231845
Identifiers
- 510(k) Number
- K231845 FDA 510(k)
- FDA Product Code
- EIA FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6640 FDA 510(k)
- Regulation Number
- 872.6640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Dental unit Model: Mare by Foshan Safety Medical Equipment Co., Ltd. — Class I — MDR, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K231845 | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Safety Medical Equipment Co., Ltd.
Sources (2)
- FDA 510(k) K231845 24 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 18, 2026