Question 1

What types of devices does GVS Filter Technology UK Ltd manufacture?

Accepted Answer

GVS Filter Technology UK Ltd manufactures single-use microbial medical gas filters, heat/moisture exchangers, suction system filters for plume particulate, combined heat/moisture exchanger and microbial medical gas filters, pulmonary function testing filters and mouthpieces, and single-use surgical irrigation tubing sets. These products are designed for specific clinical applications involving gas filtration, moisture management, and particulate control in medical settings.

Question 2

Where is GVS Filter Technology UK Ltd based?

Accepted Answer

GVS Filter Technology UK Ltd is based in the United States, as indicated in the country field of the device data. This location informs the regulatory jurisdiction under which its devices are registered and listed, particularly in relation to the FDA’s UDI system.

Question 3

In which regulatory registry are GVS Filter Technology UK Ltd's devices listed?

Accepted Answer

The devices manufactured by GVS Filter Technology UK Ltd are listed in the FDA's Unique Device Identification (UDI) system under the fda_udi registry. This listing enables traceability and regulatory oversight of individual devices in the U.S. market, though it does not imply company-wide approval or certification.

Question 4

How are the devices made by GVS Filter Technology UK Ltd classified?

Accepted Answer

The devices produced by GVS Filter Technology UK Ltd are classified as Class I and Class II medical devices. This classification reflects the level of regulatory control required based on device risk, with Class I being low risk and Class II requiring special controls. Classification applies to individual devices, not the company as a whole.

Device	Model / Reference	Registries	Class	Status
L4 New Intake Filter	3200/06AIUA058/0001	FDA UDI	Class II	Active
Multi-Vent	3000/12DIUC058/0001	FDA UDI	Class II	Active
HEPA Ventilation Filter	4020/03ABMA001/0001	EUDAMEDFDA UDI	Class II	Active
Multi-Vent	3000/11DIUC058/0001	FDA UDI	Class II	Active
Multi-vent	3000/07DAUA001/0001	FDA UDI	Class II	Active
Standard HME	6200/51BAUA069/0001	FDA UDI	Class I	Active
Tyco-Achieva Bulk	3500/01BAUA001/0001	FDA UDI	Class II	Active
Standard HMEF	6200/300BAUA069/0001	FDA UDI	Class II	Active
Multi-Vent	3000/03DAUA101/0001	EUDAMEDFDA UDI	Class II	Active
Multi-Vent	3000/04OIUA073/0001	FDA UDI	Class II	Active
Insufflation Filter	2000/18BEKAAUA058/0001	EUDAMEDFDA UDI	Class I	Active
Smoke Set	2200/47BDKBTUA123/0001	EUDAMEDFDA UDI	N/A	Active
Eco Hmef	4331/01BAUA001/0001	EUDAMEDFDA UDI	Class II	Active
Multi-vent	3000/03DAUA001/0001	EUDAMEDFDA UDI	Class II	Active
Smoke Gas Evacuation Tube Set	2200/72BTUA123/0001	EUDAMEDFDA UDI	N/A	Active
Inogen	3700/02BAUD001/0001	FDA UDI	Class II	Active
Vent Filter	2000/35BAUA001/0001	EUDAMEDFDA UDI	Class I	Active
Neo-natal HMEF	9080/100BAUA001/0001	EUDAMEDFDA UDI	Class II	Active
Spiroguard	2800/21BAUC001/0001	FDA UDI	Class II	Active
Respironics Domed (Gherkin)	3400/01AIUA058/0001	FDA UDI	Class II	Active
Insufflation Set	2200/48BIKBTUA123/0001	EUDAMEDFDA UDI	N/A	Active
ECO Range	4222/02BAUA001/0001	FDA UDI	Class II	Active
High Deadspace Body	3888/01BIUA019/0001	FDA UDI	Class II	Active
Maxi-Pleat	6888/20BAUA001/0001	EUDAMEDFDA UDI	Class II	Active
ECO Maxi Filter	4222/701BAUA001/0001	EUDAMEDFDA UDI	Class II	Active

GVS FILTER TECHNOLOGY UK LTD

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