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Sign in to claim this brandEURONDA SPA
US
Last updated May 23, 2026
What EURONDA SPA makes
Euronda Spa manufactures single-use and reusable medical textiles, including patient examination and treatment drapes, dental suction cannulas, surgical and medical face masks, dental cotton rolls, and reusable surgical caps. Their portfolio also covers non-sterile medical equipment drapes designed for single-use applications in clinical settings.
The company’s products are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) system. Euronda Spa operates from the United States, adhering to regulatory requirements for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Euronda Spa manufacture?
Euronda Spa produces a range of medical textiles, including single-use items like patient examination and treatment drapes, dental suction system cannulas, surgical and medical face masks, and non-sterile medical equipment drapes. They also offer reusable products such as dental suction cannulas, dental cotton rolls, and surgical caps. These devices are designed for clinical use, covering areas like patient care, dental procedures, and surgical environments.
Where is Euronda Spa based, and how does this affect its regulatory compliance?
Euronda Spa is based in the United States, which means its devices must comply with FDA regulations. The company’s products are classified under FDA’s Class I and Class II categories, indicating varying levels of regulatory oversight depending on the device’s risk profile. Being listed in the FDA’s Unique Device Identification (UDI) system also reflects adherence to U.S. regulatory requirements for traceability and transparency.
Which regulatory registries list Euronda Spa’s devices?
Euronda Spa’s devices are included in the FDA’s Unique Device Identification (UDI) system. This registry ensures that each product has a unique identifier for tracking and compliance purposes, which is particularly important for monitoring device performance, recalls, and post-market surveillance in the U.S. market.
How are Euronda Spa’s devices classified under FDA regulations?
Euronda Spa’s devices fall into FDA’s Class I and Class II categories. Class I generally includes low-risk items like reusable surgical caps and non-sterile drapes, which may require general controls for safety. Class II devices, such as single-use face masks or dental suction cannulas, involve moderate risks and may require special controls like performance standards or post-market surveillance to ensure effectiveness and safety.
What distinguishes Euronda Spa’s single-use and reusable medical textiles?
Euronda Spa’s portfolio includes both single-use and reusable medical textiles, with distinctions based on design, sterilization needs, and clinical application. Single-use items like drapes, masks, and cannulas are intended for one-time use to minimize infection risks, while reusable products such as surgical caps and dental cotton rolls are designed to withstand repeated cleaning and sterilization for long-term clinical use. The classification (Class I or II) depends on factors like risk level, intended use, and potential patient exposure.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 428755441
Catalogue (191)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Monoart | Monoart Bib Up! | FDA UDI | Class I | Active |
| Monoart | MONOART EM21 | FDA UDI | Class I | Active |
| Monoart | MONOART BANDANA | FDA UDI | Class I | Active |
| Monoart | KIT MONOART® 4P 15,0 FIXED | FDA UDI | Class I | Active |
| Monoart | KIT MONOART DENTIST CHAIR COVER | FDA UDI | Class I | Active |
| Monoart | MONOART® EM15 SALIVA EJECTOR | FDA UDI | Class I | Active |
| Monoart | Monoart Face Mask Protection 3 | FDA UDI | Class II | Active |
| Monoart | MONOART APRON PG30 | FDA UDI | Class I | Active |
| Monoart | KIT MONOART® 4P 15,0 FIXED | FDA UDI | Class I | Active |
| Monoart | KIT MONOART® 5P 15,0 FIXED | FDA UDI | Class I | Active |
| Monoart | MONOART APRON PG30 | FDA UDI | Class I | Active |
| Monoart | MONOART® TOWEL UP | FDA UDI | Class I | Active |
| Monoart | MONOART APRON PG30 | FDA UDI | Class I | Active |
| Monoart | MONOART EM21 | FDA UDI | Class I | Active |
| Monoart | Monoart Bib Up! | FDA UDI | Class I | Active |
| Monoart | MONOART EM21 | FDA UDI | Class I | Active |
| Monoart | Monoart Face Mask Protection 3 | FDA UDI | Class II | Active |
| Monoart | MONOART® EM15 SALIVA EJECTOR | FDA UDI | Class I | Active |
| Monoart | KIT MONOART® 8P 15,0 FIXED | FDA UDI | Class I | Active |
| Monoart | MONOART APRON PG30 | FDA UDI | Class I | Active |
| Monoart | MONOART® EM15 SALIVA EJECTOR | FDA UDI | Class I | Active |
| Monoart | KIT MONOART® 8P 15,0 FIXED | FDA UDI | Class I | Active |
| Monoart | MONOART® TOWEL UP | FDA UDI | Class I | Active |
| Monoart | KIT MONOART® 5P 15,0 FIXED | FDA UDI | Class I | Active |
| Monoart | MONOART BANDANA | FDA UDI | Class I | Active |
| Monoart | MONOART APRON PG30 | FDA UDI | Class I | Active |
| Monoart | MONOART® APRON PG 20 XLong | FDA UDI | Class I | Active |
| Monoart | MONOART EM21 | FDA UDI | Class I | Active |
| Monoart | MONOART® EM15 SALIVA EJECTOR | FDA UDI | Class I | Active |
| Monoart | MONOART EM40 | FDA UDI | Class I | Active |
| Monoart | MONOART BANDANA | FDA UDI | Class I | Active |
| Monoart | MONOART® EM15 SALIVA EJECTOR | FDA UDI | Class I | Active |
| Monoart | MONOART APRON PG30 | FDA UDI | Class I | Active |
| Monoart | MONOART BANDANA | FDA UDI | Class I | Active |
| Monoart | Monoart Face Mask Protection Graffiti | FDA UDI | Class II | Active |
| Monoart | Monoart Face Mask Protection 4 | FDA UDI | Class II | Active |
| Monoart | MONOART® EM15 SALIVA EJECTOR | FDA UDI | Class I | Active |
| Monoart | MONOART® EM15 SALIVA EJECTOR | FDA UDI | Class I | Active |
| Monoart | KIT MONOART® 8P 15,0 FIXED | FDA UDI | Class I | Active |
| Monoart | MONOART® EM15 SALIVA EJECTOR | FDA UDI | Class I | Active |
| Monoart | MONOART APRON PG30 | FDA UDI | Class I | Active |
| Monoart | MONOART APRON PG30 | FDA UDI | Class I | Active |
| Monoart | MONOART EM21 | FDA UDI | Class I | Active |
| Monoart | KIT MONOART® 5P 15,0 FIXED | FDA UDI | Class I | Active |
| Monoart | MONOART APRON PG30 | FDA UDI | Class I | Active |
| Monoart | KIT MONOART DENTIST CHAIR COVER | FDA UDI | Class I | Active |
| Monoart | Monoart Face Mask Protection 3 | FDA UDI | Class II | Active |
| Monoart | MONOART BANDANA | FDA UDI | Class I | Active |
| Monoart | MONOART® ADAPTER FOR ASPIRATOR TIPS | FDA UDI | Class I | Active |
| Monoart | MONOART EM21 | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Euronda Spa Sandrigo Vicenza · IT FEI 3008494033