EU → North America Device Access

Intersurgical Ltd

GB-MF-000004798 · United Kingdom · Wokingham

Intersurgical Ltd is registered in the European database on medical devices as a manufacturer, with 94 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa79
Class IIb15

Most frequent device types declared: InterActive.

Among these devices, 17 are declared active.

Authorised representative in the Union: UAB Intersurgical.

Catalogue references include 1691040, 3011000, 3026000, 4700011, 4707004, 4907008.

European nomenclature codes declared: V9099, R01058099, R060201, R028099, Z12159009, Q0199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryINTERSURGICAL LTD. (GB) · FDA 3002807267
Devices in EUDAMED94
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN94
Found in the U.S. device database27
Share28.7 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryINTERSURGICAL LTD.

What it holds in Canada

Licences on record62
Currently active0
Class 2 devices62
First licensed1999-06-10

Licence types: Device Family (38), Single Device (11), Device Group Family (10), System (2).

Licensed under: NEOPRENE RESERVOIR BAGS - LATEX FREE, LATEX FREE SILICONE ANAESTHETIC FACE MASKS, BREATHING SYSTEM (VENTILATOR) TUBING - SILICON, NEOPRENE ANATOMICAL FACE MASKS - LATEX FREE, HUMIDIFIER ELECTRICAL ADAPTOR LEADS, LARYNGOSCOPE BLADES.

North American profile: Both markets. Intersurgical Ltd is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
ITH 2534789 1supplemented2029-04-11

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