Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040997701

FEI Number

3040997701

Entity Name

S.P.F. PLASTICS B.V.

City/State/Country

Zaltbommel Gelderland, NL

Establishment Address

Toepadweg 3, Zaltbommel Gelderland 5301KA, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

S.P.F. Plastics B.V. (Owner Number: 10094508)

Owner / Operator Contact Address

Toepadweg 3, Zaltbommel, NL-GE 5301KA, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2025-12-04

Official Correspondent

Wilfred Hijman

US Agent Details

Naveen Kaki Email: naveen.kaki@epredia.com Phone: (857) 2631783

Related Public Records

Same Entity

S.P.F. Plastics B.V.

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

View Entity Profile →

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3003584784	SHANDON DIAGNOSTICS LIMITED	RUNCORN Cheshire East, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040997701. Last updated year: 2026. Please use registration number 3040997701 when referencing this establishment in official correspondence.