Question 1

What types of medical devices does G-Flex Flexible Instruments Europe manufacture?

Accepted Answer

G-Flex Flexible Instruments Europe specialises in reusable medical instruments for clinical use. Their portfolio includes biopsy forceps, which are used for obtaining tissue samples during procedures, and lithotripsy systems, designed to fragment kidney stones. All listed devices are intended for non-sterile, reusable applications and require cleaning and reprocessing between uses.

Question 2

Where is G-Flex Flexible Instruments Europe based?

Accepted Answer

The company is headquartered in Belgium, where it operates as a manufacturer of reusable medical devices for biopsy and lithotripsy applications. Its location ensures compliance with EU regulatory standards for medical devices.

Question 3

Are G-Flex Flexible Instruments Europe’s devices listed in any regulatory registries?

Accepted Answer

Yes, all of G-Flex Flexible Instruments Europe’s devices are listed in the EUDAMED database. This registry is the official EU system for tracking medical devices, ensuring transparency and traceability of authorised products within the European market.

Question 4

How are G-Flex Flexible Instruments Europe’s devices classified under EU regulations?

Accepted Answer

G-Flex Flexible Instruments Europe’s devices fall into two classification categories under EU medical device regulations: Class I and Class IIa. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient safety. For example, biopsy forceps and lithotripsy systems are assessed based on their procedural risks and clinical applications.

Device	Model / Reference	Registries	Class	Status
Sterile Sclerotherapy & Endoscopic Needles	GF262302	EUDAMEDFDA UDI	Class IIa	Active
Inflation Devices	INFL40	EUDAMED	Class I	Active
Sterile Disposable Biopsy Forceps	U160C	EUDAMEDFDA UDI	Class IIa	Active
Sterile Non-Vascular Guidewires	GW01-25450	EUDAMED	Class IIa	Active
Stent application system	DISS08U	EUDAMED	Class I	Active
Sterile Sclerotherapy & Endoscopic Needles	GF252203	EUDAMEDFDA UDI	Class IIa	Active
Cleaning Brush	GF4120	EUDAMED	Class I	Active
Endoscope Valves Set	U7100-P	EUDAMED	Class I	Active
Multiband Ligator	GF-OVL501	EUDAMED	Class IIa	Active
Sterile Disposable Biopsy Forceps	U120C	EUDAMEDFDA UDI	Class IIa	Active
Cleaning Brush	GF4114	EUDAMED	Class I	Active
Non-Sterile Reusable Foreign Body Retrievers	22522230	EUDAMED	Class I	Active
Endoscope Valves Set	U7101-F	EUDAMED	Class I	Active
Sterile Disposable Biopsy Forceps	U230	EUDAMEDFDA UDI	Class IIa	Active
Sterile Stone Extraction Balloon Catheter	GF135716	EUDAMED	Class IIa	Active
Sterile Stone Extraction Balloon Catheter	GF135716T	EUDAMED	Class IIa	Active
Endoscope Valves Set	U7001-O	EUDAMED	Class I	Active
Sterile Disposable Endoscopic Forceps & Retrievers	GF4500	EUDAMED	Class I	Active
Sterile Sclerotherapy & Endoscopic Needles	GF252203-25	EUDAMEDFDA UDI	Class IIa	Active
Endoscope Valves Set	U7000-P	EUDAMED	Class I	Active
Lithotripsy System	GF500	EUDAMED	Class I	Active
Sterile Disposable Endoscopic Forceps & Retrievers	GF1222	EUDAMED	Class I	Active
Sterile Non-Vascular Guidewires	GW02-35300	EUDAMED	Class IIa	Active
Inflation Devices	INFL60	EUDAMED	Class I	Active
Polyp Trap	GF4901	EUDAMED	Class I	Active
Sterile Disposable Biopsy Forceps	U422-230LC	EUDAMEDFDA UDI	Class IIa	Active
Sterile Disposable Biopsy Forceps	U230C	EUDAMEDFDA UDI	Class IIa	Active
Polyp Trap	GF4905	EUDAMED	Class I	Active
Sterile Disposable Endoscopic Forceps & Retrievers	GF4502	EUDAMED	Class I	Active

G-FLEX FLEXIBLE INSTRUMENTS EUROPE

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