EURONDA SPA

FDA Device Registration & Listing · Sandrigo Vicenza, IT · Registration 3008494033

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008494033
FEI Number
3008494033
Entity Name
EURONDA SPA
City/State/Country
Sandrigo Vicenza, IT
Establishment Address
Via Chizzalunga 1, Sandrigo Vicenza 36066, IT
Establishment Type(s)
Foreign Private Label Distributor
Owner / Operator
EURONDA SPA (Owner Number: 10033261)
Owner / Operator Contact Address
via Dell'Artigianato 7, MONTECCHIO PRECALCINO, VICENZA, IT-VI 36030, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2010-07-28
EFS Unit, Oral Irrigation Dental Class 1 872.6510 2025-07-09
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2018-10-11
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2015-05-27
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2015-05-27
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 2018-10-19
KHR Absorber, Saliva, Paper Dental Class 1 872.6050 2015-05-27
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2024-10-18
EFN Cotton, Roll Dental Class 1 872.6050 2015-05-27

Official Correspondent

Andre Nichele

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

EURONDA SPA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K781592 Henry Schein, Inc. SURGICAL ASPIRATOR TIPS 1978-12-04
K844318 Pro Pulse, Inc. ORAL IRRIGATION TIP 1984-11-23
K880871 John Wagner Associates, Inc. GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER 1988-05-20
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0505-2022 Philips North America Llc 1
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022 Philips North America Llc 1
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0019-2023 Hobbs Medical, Inc. 1
Hobbs Scope Introducer Catalog Number: 4650
Z-0007-2013 Invuity, Inc. 2
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

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3016789258 EG-MEDACYS DEVICES(SHENZHEN)CO.,LTD SHENZHEN Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008494033. Last updated year: 2026. Please use registration number 3008494033 when referencing this establishment in official correspondence.
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