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.
FEILookup · DWPERadarFEI + OASIS + 483
OFFICIAL OPENFDA FEI RECORDFEI: 1000168975Reg Yr: 2027Germany (DE)

STORK INSTRUMENTE GMBH

Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for STORK INSTRUMENTE GMBH (FEI 1000168975). 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

ENGENERSTR. 29

Emmingen-Liptingen Baden-Wurttemberg, Germany (78576)

FDA FURLS Identifiers

FEI Number: 1000168975

Registration No: 8010547 • Status Code: 1 (Active)

Designated U.S. Agent21 CFR 807.40

Franz Menean

MEDAGENT Inc.

Portsmouth, NH (USA)

603-5702039

mail@medagent-usa.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?
FGMProbe And Director, Gastro-UrologyClass 121 CFR 876.4730 Requires 510(k) / Check
FSVP AUDIT WORKBOOKS & REAL-TIME OASIS DETENTION ALERTSFEI #1000168975 • Instant Delivery
5-Year Cleaned Excel Pack$39 One-Time

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 STORK INSTRUMENTE GMBH (FEI 1000168975) + category peers
  • 21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab
FEI #1000168975 Watchdog$15 / month

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 STORK INSTRUMENTE GMBH (FEI 1000168975) before you wire your 70% balance payment.

Enter a corporate email address to receive FEI #1000168975 detention alerts.

Please enter a valid work email address (e.g., ops@company.com).

Optional HTTPS endpoint for automated JSON refusal payloads.

Please enter a valid https:// webhook URL or leave blank.

Other Verified FDA FEI Establishments in Germany

Frequently Asked Questions: FEI 1000168975 (STORK INSTRUMENTE GMBH)

What is the FDA FEI Number for STORK INSTRUMENTE GMBH?

According to public US FDA Establishment Registration records, STORK INSTRUMENTE GMBH (Emmingen-Liptingen Baden-Wurttemberg, Germany) is assigned FDA Facility Establishment Identifier (FEI) 1000168975 (Registration No. 8010547) with registration year 2027.

Who is the designated US Agent for FEI 1000168975 (STORK INSTRUMENTE GMBH)?

The registered US Agent on file for FEI 1000168975 is Franz Menean (MEDAGENT Inc.) located in Portsmouth, NH. Importers should independently confirm active representation before filing CBP ACE entry.

Does an active FDA FEI registration guarantee that shipments from STORK INSTRUMENTE GMBH 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.