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, composed by 4 layers: .Soft, colored and water-repellent non-woven fabric with floral motifs; .PFE (Particle Filtration Efficiency) filter and BFE (Bacterial Filtration Efficiency); .2 layers of comfortable, non-woven cotton lining for extra absorbance of sweat and humidity when used by operators. It is ideal for protection from dust and aerosols in accordance with the EN14683 standard (differential pressure: surgical mask breathability rating). Built-in nose bridge. Colour: floral lilac Box of 50 masks FDA UDI
- Model / Reference
- Monoart Face Mask Protection 3 FDA UDI
- Description
- Disposable hypo-allergenic face mask, composed by 4 layers: .Soft, colored and water-repellent non-woven fabric with floral motifs; .PFE (Particle Filtration Efficiency) filter and BFE (Bacterial Filtration Efficiency); .2 layers of comfortable, non-woven cotton lining for extra absorbance of sweat and humidity when used by operators. It is ideal for protection from dust and aerosols in accordance with the EN14683 standard (differential pressure: surgical mask breathability rating). Built-in nose bridge. Colour: floral lilac Box of 50 masks FDA UDI
Identifiers
- Catalog Number
- 217122 FDA UDI
- Primary DI / UDI-DI
- E3072171220 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 6bb68088-8203-4981-9c00-a632ba79e1f7 34 fields · synced Jun 1, 2026