HomeUnited Kingdom of Great Britain and Northern IrelandCORE SURGICAL LIMITED

CORE SURGICAL LIMITED

United Kingdom of Great Britain and Northern Ireland · Thame Oxfordshire
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
2listed device types
Class I 1Class II 1Class III 0
plus 2 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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 States2 registration records, 1 510(k), 0 PMA, 29 excluded
Brazil0 confirmed, 6 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: CORE SURGICAL LIMITED · CORE ACCESS SURGICAL TECHNOLOGIES, INC.
Same-named companies — This database also contains companies with near-identical names: CORE ACCESS SURGICAL TECHNOLOGIES, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Thame Oxfordshire

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
03649172
Registration status
Active
Legal form
Private Limited Company
Incorporated
1998-10-14
Principal activity
32500 - Manufacture of medical and dental instruments and supplies / 46900 - Non-specialised wholesale trade
Registered address
UNIT 3, BANBURY, OX16 2RT

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

12022 · K212786

FDA listed device types

Knife, Ophthalmic 1Insufflator, Laparoscopic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK212786LevaLap Laparoscopic Access Device2022-02-23

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