Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008274780

FEI Number

3008274780

Entity Name

G-FLEX EUROPE SRL

City/State/Country

Nivelles Brabant Wallon, BE

Establishment Address

20 Rue de l'Industrie, Nivelles Brabant Wallon 1400, BE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

G-flex Europe Srl (Owner Number: 10082053)

Owner / Operator Contact Address

20 Rue de l'Industrie, Nivelles, BE-WBR 1400, BE

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
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-06-17
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2021-06-10
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2021-06-10

Official Correspondent

Laura Boll

US Agent Details

Laura Boll Business: Diversatek Healthcare Email: lboll@diversatek.com Phone: (414) 7554806

Related Public Records

Same Entity

G-flex Europe Srl

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008274780. Last updated year: 2026. Please use registration number 3008274780 when referencing this establishment in official correspondence.