Identity
- Trade Name
- Monoart FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- Disposable, hypo-allergenic face mask with 3 layers: • Soft, coloured and water-repellent non-woven fabric for improved protection against dust and humidity; • PFE (Particle Filtration Efficiency) filter and BFE (Bacterial Filtration Efficiency) filter; • Comfortable non-woven cotton lining for extra absorbance of sweat and humidity. It is ideal for protection from dust and aerosols in accordance with the EN 14683 standard (differential pressure: surgical mask breathability rating). Built-in nose bridge. Box of 50 masks. Color: green FDA UDI
- Model / Reference
- Monoart Face Mask Protection 3 FDA UDI
- Description
- Disposable, hypo-allergenic face mask with 3 layers: • Soft, coloured and water-repellent non-woven fabric for improved protection against dust and humidity; • PFE (Particle Filtration Efficiency) filter and BFE (Bacterial Filtration Efficiency) filter; • Comfortable non-woven cotton lining for extra absorbance of sweat and humidity. It is ideal for protection from dust and aerosols in accordance with the EN 14683 standard (differential pressure: surgical mask breathability rating). Built-in nose bridge. Box of 50 masks. Color: green FDA UDI
Identifiers
- Catalog Number
- 217114 FDA UDI
- Primary DI / UDI-DI
- E3072171140 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical/medical face mask, non-antimicrobial, single-use
Monoart by Euronda Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Euronda Spa
Sources (1)
- FDA UDI c29ef95e-d996-4f44-b565-89675d5a2d35 34 fields · synced May 30, 2026