FDA Registration
Active
🇮🇹 Italy
EURONDA SPA
Reg #: 3008494033
·
FEI: 3008494033
·
Expires 2026
Products
11
Proprietary Names
24
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- EURONDA SPA
- Registration Number
- 3008494033
- FEI Number
- 3008494033
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Chizzalunga 1
- City
- Sandrigo Vicenza
- Country
- IT
Owner / Operator
- Firm Name
- EURONDA SPA
- Operator Number
- 10033261
- Address
- via Dell'Artigianato 7, MONTECCHIO PRECALCINO
- City
- VICENZA
- State
- IT-VI
- Postal Code
- 36030
- Country
- IT
- Correspondent
- Andre Nichele
US Agent
- Business Name
- THEMA CORP
- Contact Name
- Silvia Tamarri
- Address
- 2929 Arch Street
- City
- Philadelphia
- State
- PA
- ZIP
- 19104
- Country
- US
- [email protected]
- Phone
- 215 8459459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2010-07-28 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2025-07-09 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2018-10-11 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2015-05-27 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2015-05-27 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2018-10-19 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2015-05-27 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2024-10-18 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2015-05-27 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2018-10-11 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2017-12-11 |
Proprietary Names
MONOART EM15 SALIVA EJECTOR
Manual Irrigation Set
Irrigation Set For Machinery
Tubing Extension For Mechanical Irrigation Set
Monoart Instant Ice
MONOART EM19
MONOART EM40
MONOART EM21
MONOART FACE MASK PROTECTION 3
MONOART® FACE MASK PROTECTION 4
MONOART® FACE MASK PROTECTION 4 SENSITIVE
MONOART® FACE MASK PROTECTION 3 FLORAL
Monoart® Adattatore per Cannula
MONOART TOWEL UP
MONOART APRON PG30
MONOART TOWEL
KIT MONOART® 4P 15,0 FIXED
MONOART APRON PG20
KIT MONOART® 8P 15,0 FIXED
KIT MONOART® 5P 15,0 FIXED
EM45 SurgiFlexo Tip
MONOART COTTON ROLLS
Kit Monoart Dentist Chair Cover
Monoart Bandana
Establishment Types
Manufacture Medical Device
Foreign Private Label Distributor