Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002958688

FEI Number

3002958688

Entity Name

ENESTIA BELGIUM NV (SHARP BELGIUM)

City/State/Country

Hamont-Achel Limburg, BE

Establishment Address

Klocknerstraat 1, Hamont-Achel Limburg 3930, BE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Enestia Belgium NV (Sharp Belgium) (Owner Number: 10093022)

Owner / Operator Contact Address

Klocknerstraat 1, Hamont-Achel, BE-VLI 3930, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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	2025-03-19

Official Correspondent

Anouk Haselaars

US Agent Details

Margaret Grace Breen Business: Sharp Packaging Services, LLC Email: grace.breen@sharpservices.com Phone: (484) 8660113

Related Public Records

Same Entity

Enestia Belgium NV (Sharp Belgium)

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 3002958688. Last updated year: 2026. Please use registration number 3002958688 when referencing this establishment in official correspondence.