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U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/Roll
FDA 510(k)Class II (US FDA 510(k))
510(k) K123162
Identifiers
- 510(k) Number
- K123162 FDA 510(k)
- FDA Product Code
- FRG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/Roll by U&U Medical Technology Co, Ltd. — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123162 | Class II | Active |
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Manufacturer
- Manufacturer
- U&U Medical Technology Co, Ltd.
Sources (1)
- FDA 510(k) K123162 24 fields · synced Jun 18, 2026