2026 CBP ACE & FDA OASIS Enforcement Update: MoCRA Cosmetic FEI & QMSR Device 510(k) Affirmation of Compliance cross-checks are active at Los Angeles, Newark, Miami & Savannah ports.
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OFFICIAL OPENFDA FEI RECORDFEI: 3003752502Reg Yr: 2027Italy (IT)

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.

Registered Facility Address

Strada Statale 12, n. 143

Medolla Modena, Italy (41036)

FDA FURLS Identifiers

FEI Number: 3003752502

Registration No: 3003752502 • Status Code: 1 (Active)

Designated U.S. Agent21 CFR 807.40

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 CodeFDA Classification NameDevice Class21 CFR Regulation510(k) Exempt?
DTZOxygenator, Cardiopulmonary BypassClass 221 CFR 870.4350 Requires 510(k) / Check
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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.

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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.