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: 3005698350Reg Yr: 2026India (IN)

STAAN BIOMED ENGINEERING PRIVATE LIMITED

Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for STAAN BIOMED ENGINEERING PRIVATE LIMITED (FEI 3005698350). 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

190-A, BHARATHIAR ROAD, GANAPATHY

COIMBATORE Tamil Nadu, India (641006)

FDA FURLS Identifiers

FEI Number: 3005698350

Registration No: 3005698350 • Status Code: 1 (Active)

Designated U.S. Agent21 CFR 807.40

Manoj Zacharias

Liberty Management Group Ltd.

Aurora, IL (USA)

630-2702921

office@libertymanagement.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

HALOGEN LIGHT -EL 700/500SPIDER LED- STAAN 620DISCOVER LED LIGHT – 750/650/550BUTTERFLY LED -700PETAL LED
Product CodeFDA Classification NameDevice Class21 CFR Regulation510(k) Exempt?
FSYLight, Surgical, Ceiling MountedClass 221 CFR 878.4580 Requires 510(k) / Check
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Other Verified FDA FEI Establishments in India

Frequently Asked Questions: FEI 3005698350 (STAAN BIOMED ENGINEERING PRIVATE LIMITED)

What is the FDA FEI Number for STAAN BIOMED ENGINEERING PRIVATE LIMITED?

According to public US FDA Establishment Registration records, STAAN BIOMED ENGINEERING PRIVATE LIMITED (COIMBATORE Tamil Nadu, India) is assigned FDA Facility Establishment Identifier (FEI) 3005698350 (Registration No. 3005698350) with registration year 2026.

Who is the designated US Agent for FEI 3005698350 (STAAN BIOMED ENGINEERING PRIVATE LIMITED)?

The registered US Agent on file for FEI 3005698350 is Manoj Zacharias (Liberty Management Group Ltd.) located in Aurora, IL. Importers should independently confirm active representation before filing CBP ACE entry.

Does an active FDA FEI registration guarantee that shipments from STAAN BIOMED ENGINEERING PRIVATE LIMITED 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.