Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614577

FEI Number

3002539673

Entity Name

LEJA PRODUCTS B.V.

City/State/Country

NIEUW VENNEP Noord-Holland, NL

Establishment Address

LUZERNESTRAAT 10, NIEUW VENNEP Noord-Holland 2153 GN, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LEJA PRODUCTS B.V. (Owner Number: 9036023)

Owner / Operator Contact Address

LUZERNESTRAAT 10, --, NIEUW VENNEP, NL-NOTA 2153 GN, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LEJA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GHO	Hemocytometer	Hematology	Class 1	864.6160	1998-12-30

Official Correspondent

ANNE LINDA VAN KAPPEL

US Agent Details

Annelise Jensch Business: Spectrum Technologies, Inc Email: info@yourpurespermsource.com Phone: (707) 4338990

Related Public Records

Same Entity

LEJA PRODUCTS B.V.

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 9614577. Last updated year: 2026. Please use registration number 9614577 when referencing this establishment in official correspondence.