Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038138498

FEI Number

3038138498

Entity Name

SYNTHON B.V.

City/State/Country

Nijmegen Gelderland, NL

Establishment Address

Microweg 22, Nijmegen Gelderland 6545, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Synthon B.V. (Owner Number: 10092950)

Owner / Operator Contact Address

Microweg 22, Nijmegen, NL-GE 6545, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243232

PMA Number

N/A

All Registered Proprietary Names

GripMate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2025-03-10

Official Correspondent

Virginia Lopez

US Agent Details

Rebecca (Becky) Welton Business: Lachman Consultant Services, Inc. Email: lcsreg@lachmanconsultants.com Phone: (516) 2226222

Related Public Records

Same Entity

Synthon 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 3038138498. Last updated year: 2026. Please use registration number 3038138498 when referencing this establishment in official correspondence.