Eurosets s.r.l.
Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for Eurosets s.r.l. (FEI 3003752502). Use this record to cross-check CBP ACE Affirmation of Compliance codes (`DEV` / `DFE` / `FEI`), verify the designated US Agent on file, and subscribe to automated Import Alert (DWPE) monitoring.
Strada Statale 12, n. 143
Medolla Modena, Italy (41036)
FEI Number: 3003752502
Registration No: 3003752502 • Status Code: 1 (Active)
Sebastian Feye
Accurate Consultants Inc.
San Diego, CA (USA)
619-5170673
sebastian@accuratefdaconsulting.com
Registered FDA Product Codes, Device Classes & Commercial Names
Cross-check your commercial invoice product descriptions against these active FDA product code filings to prevent NO_510K or UNAPPROVED_NEW_DRUG port holds.
| Product Code | FDA Classification Name | Device Class | 21 CFR Regulation | 510(k) Exempt? |
|---|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | Class 2 | 21 CFR 870.4350 | Requires 510(k) / Check |
Download Normalized 5-Year Refusal, 483 & Recall Audit Workbook (.XLSX + CSV)
Includes all deduplicated overseas factory names, FEI/DUNS crosswalks, 5-year port refusal logs, plain-English statutory violation mappings, and FSVP supplier qualification templates ready for customs broker review.
- Full 5-year OASIS refusal history for Eurosets s.r.l. (FEI 3003752502) + category peers
- 21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab
Instant Supplier Detention Webhook & Email Alert Monitor
Get an automated Slack/Webhook JSON payload and email alert within 15 minutes whenever FDA OASIS logs a new detention, Import Alert Red List addition, or Warning Letter for Eurosets s.r.l. (FEI 3003752502) before you wire your 70% balance payment.
Shipment Detained by FDA or Placed on Import Alert? Request Free 24h Detention Evaluation from Licensed US FDA Compliance Counsel
When FDA issues a Notice of FDA Action (Detention), importers typically have only 10 to 20 business days to file a Form FDA 766 relabeling application, submit an accredited private laboratory packet (PLAP), or petition for Import Alert Red List removal before CBP orders refusal and liquidated damages.
Other Verified FDA FEI Establishments in Italy
Frequently Asked Questions: FEI 3003752502 (Eurosets s.r.l.)
What is the FDA FEI Number for Eurosets s.r.l.?
According to public US FDA Establishment Registration records, Eurosets s.r.l. (Medolla Modena, Italy) is assigned FDA Facility Establishment Identifier (FEI) 3003752502 (Registration No. 3003752502) with registration year 2027.
Who is the designated US Agent for FEI 3003752502 (Eurosets s.r.l.)?
The registered US Agent on file for FEI 3003752502 is Sebastian Feye (Accurate Consultants Inc.) located in San Diego, CA. Importers should independently confirm active representation before filing CBP ACE entry.
Does an active FDA FEI registration guarantee that shipments from Eurosets s.r.l. will clear US Customs without detention?
No. An active FDA FEI number or establishment registration only confirms administrative listing in FDA FURLS. Shipments can still be detained at US ports under Detention Without Physical Examination (DWPE / Import Alerts) for labeling, 510(k), cGMP, or adulteration violations.