HomeUnited Kingdom of Great Britain and Northern IrelandSurgical Innovations Group Plc

Surgical Innovations Group Plc

United Kingdom of Great Britain and Northern Ireland · Leeds
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Hong Kong, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
36listed device types
Class I 26Class II 7Class III 1unclassified 2
plus 50 registration records and 44 510(k), 7 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
35registered devices
Class I 17Class II 18
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
10registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
6active device licences
Class II 6
28 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 2IIa 1IIb 2
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States50 registration records, 44 510(k), 7 PMA, 233 excluded
Brazil35 confirmed, 26 excluded
Saudi Arabia10 confirmed, 5 excluded
Canada6 confirmed, 36 excluded
Manufacturer names merged into this page: MISSION SURGICAL INNOVATIONS · DAVOL SURGICAL INNOVATIONS · TEDAN SURGICAL INNOVATIONS, INC. · SURGICAL INNOVATIONS LTD · GENERAL SURGICAL INNOVATIONS, INC. · SURGICAL INNOVATIONS LIMITED

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Leeds

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Company number
02298163
Registration status
Active
Legal form
Public Limited Company
Incorporated
1988-09-20
Principal activity
32500 - Manufacture of medical and dental instruments and supplies
Registered address
CLAYTON WOOD HOUSE 6, LEEDS, LS16 6QZ

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

31996
41997
11998
11999
12001
12002
12003
42004
22006
12007
12008
22010
22012
22013
12014
12017
12019
12021
12023
12026

FDA listed device types

showing 8 of 36
Rasp 1Probe 1Operating Room Accessories Table Tray 1Screwdriver 1Device, Incontinence, Urosheath Type, Non-Sterile 1Driver, Surgical, Pin 1Stylet For Catheter, Gastro-Urology 1Gauge, Depth 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)2026-04-26
USK231691Phantom XL Insulated Dilators2023-06-29
USK210495Port Access System2021-06-18
BR80978563786Instrumentais para Cirurgia de Coluna IIClass I
BR10355870366INSTRUMENTOS CIRÚRGICOS TSI COPOLÍMEROSClass I
BR80444810108Phantom AL – Sistema Retrator de Acesso AnteriorClass I
SAME0000003139SFDAA00007FastClamp Bariatric Bar
SAME0000003139SFDAA00011Table Clamp
CA5342SPACEMAKER SURGICAL BALLOON DISSECTORClass II
CA69508YELLOPORT CANNNULAClass II
CA87920QUICK - SINGLE USE INSTRUMENTS FOR LAPAROSCOPIC SURGERYClass II

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