OFFICIAL OPENFDA FEI RECORDFEI: 3003268355Reg Yr: 2027Germany (DE)

EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG

Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG (FEI 3003268355). 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

EUROIMMUN AG, Seekamp 31

Luebeck Schleswig-Holstein, Germany (D-23560)

FDA FURLS Identifiers

FEI Number: 3003268355

Registration No: 3003268355 • Status Code: 1 (Active)

Designated U.S. Agent21 CFR 807.40

Faith Du

Mountain Lakes, NJ (USA)

973-6561000

ra-us@euroimmun.us

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.

Proprietary / Commercial Brand Names on File

Anti-CCP ELISA (IgG)

Product Code	FDA Classification Name	Device Class	21 CFR Regulation	510(k) Exempt?
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Class 2	21 CFR 866.5775	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 EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG (FEI 3003268355) before you wire your 70% balance payment.

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Work Email for 24h Legal Memo (Required)

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Importer Website or Amazon/Shopify Store URL (Required)

Include https:// so counsel can pre-screen product Intended Use claims.

Please enter a valid URL starting with https:// or http://.

CBP Entry Number or Supplier FEI # (Required)

Format: 10-digit FEI (e.g., 3003268355) or 11-char CBP Entry # (e.g., W94-8829104-3).

Enter a 5–24 character alphanumeric FEI number or CBP Entry number.

US Port of Detention

Select the FDA District / Port holding the cargo.

Primary Cited FDA Charge Code

Charge listed on your Notice of FDA Action.

Commercial Cargo Value at Risk

Determines Form 766 vs. PLAP economic viability.

Notice of FDA Action Summary & Respond-By Date (Optional)

Describe whether cargo is currently on hold in ITACS, whether private lab sampling has started, or if you need an Import Alert removal petition.

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Frequently Asked Questions: FEI 3003268355 (EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG)

What is the FDA FEI Number for EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG?

According to public US FDA Establishment Registration records, EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG (Luebeck Schleswig-Holstein, Germany) is assigned FDA Facility Establishment Identifier (FEI) 3003268355 (Registration No. 3003268355) with registration year 2027.

Who is the designated US Agent for FEI 3003268355 (EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG)?

The registered US Agent on file for FEI 3003268355 is Faith Du located in Mountain Lakes, NJ. Importers should independently confirm active representation before filing CBP ACE entry.

Does an active FDA FEI registration guarantee that shipments from EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG 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.