Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2419564

FEI Number

2434772

Entity Name

LEECHES U.S.A. LTD.

City/State/Country

WESTBURY, NY, US

Establishment Address

300 SHAMES DR., WESTBURY, NY 11590, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

LEECHES U.S.A. LTD. (Owner Number: 9003163)

Owner / Operator Contact Address

300 SHAMES Drive, --, Westbury, NY 11590, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK251211

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRN	Leeches, Medicinal	Unknown	Class U	N/A	2013-03-07
NRN	Leeches, Medicinal	Unknown	Class U	N/A	2025-08-04

Official Correspondent

MARIE BONAZINGA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LEECHES U.S.A. LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2419564. Last updated year: 2026. Please use registration number 2419564 when referencing this establishment in official correspondence.