Identity
- Trade Name
- Molekule Air Mini + FDA UDI
- Generic Name
- Ultraviolet ambient disinfection light FDA UDI
- Device Name
- The Molekule Air Mini air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation FDA UDI
- Model / Reference
- MN1P-US FDA UDI
- Description
- The Molekule Air Mini air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818701020537 FDA UDI
- 510(k) Number
- K202339 FDA UDI
- FDA Product Code
- FRA FDA UDI
- GMDN Term
- Ultraviolet ambient disinfection light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultraviolet ambient disinfection light
Molekule Air Mini + by Molekule, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultraviolet ambient disinfection light.
- UV Smart — UV Smart Technologies B.V. · Class II
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- Hepa-Care® — Abatement Technologies, Inc. · Class II
- Hepa-Care® — Abatement Technologies, Inc. · Class II
- Hepa-Care® — Abatement Technologies, Inc. · Class II
- Molekule Air Pro — Molekule, Inc. · Class II
- Molekule — Molekule, Inc. · Class II
- Molekule Air Mini — Molekule, Inc. · Class II
Cleared under the same submission
K202339 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Molekule, Inc.
Sources (1)
- FDA UDI 8d2657c5-2d1b-4d58-8a9d-691c93830232 35 fields · synced May 30, 2026