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HAEMOBAND SURGICAL LTD

Matched from indexed company URL: Haemoband Surgical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30073881243007388124HAEMOBAND SURGICAL LTD1N2026-01-01The Mount Conference Centre 2 Woodstock Link Belfast Northern Ireland GB BT6 8DD

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1119541954192832K250645SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)FER2025-10-09
1119541778317524K091519HAEMOBAND MULTI-LIGATORFHN2009-07-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FER12025-10-09
FHN12009-07-28

PMN#

GUDID#

Haemoband-PLUS Band Ligator - Haemoband-PLUS Band Ligator is a class 2 latex free, single use, disposable instrument (medical device) used for the band ligation of internal 1st, 2nd, and 3rd degree hemorrhoids. The Haemoband-PLUS Band Ligator device must only be used by trained professionals. The Haemoband-PLUS Band Ligator is an automated multi-ligator applicator device, comprising a one-piece plastic gun with four main components• an insertion barrel or probe• a protector firing nozzle, pre-loaded with four bands; and• an innovative dual grip and firing mechanism• universal suction connectorThe device is to be attached to a standard suction supply via the universal connector on the handle. The trigger is then partially depressed to induce suction, then depressed fully to release the band onto the hemorrhoidal tissue secured. Grip from the trigger is then released with the next band automatically reloaded, ready for next band application.

Haemoband Surgical

2026-04-28