HomeUnited Kingdom of Great Britain and Northern IrelandPURPLE SURGICAL INTERNATIONAL LIMITED

PURPLE SURGICAL INTERNATIONAL LIMITED

United Kingdom of Great Britain and Northern Ireland · Shenley
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Israel — 7 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
14listed device types
Class I 9Class II 5Class III 0
plus 13 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class II 5
8 including historic records
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
18 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
7device registrations
CLASS B 7
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
28active ARTG entries
Class I 5IIa 9IIb 5Class Is (sterile) 9
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States13 registration records, 1 510(k), 0 PMA, 4 excluded
Brazil5 confirmed, 1 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: PURPLE SURGICAL INTERNATIONAL LIMITED · PURPLE SURGICAL INTERNATIONAL LIMITED / PURPLE SURGICAL UK LIMITED · PURPLE SURGICAL INTERNATIONAL LTD. · Purple Surgical
Same-named companies — This database also contains companies with near-identical names: PURPLE SURGICAL INTERNATIONAL LIMITED / PURPLE SURGICAL UK LIMITED. 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
Shenley

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
03930014
Registration status
Active
Legal form
Private Limited Company
Incorporated
2000-02-21
Principal activity
32500 - Manufacture of medical and dental instruments and supplies
Registered address
2 CHESTNUT HOUSE, SHENLEY, WD7 9AD

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

12014 · K142868

FDA listed device types

showing 8 of 14
Tubing/Tubing With Filter, Insufflation, Laparoscopic 1Container, Specimen, Non-Sterile 1Bag, Intestine 1Dissector, Surgical, General & Plastic Surgery 1Camera, Surgical And Accessories 1Needle, Aspiration And Injection, Disposable 1Tubing, Pressure And Accessories 1Curette, Surgical, General Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK1428685mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin2014-11-21
BR82939369002Agulha de Veress UltimateClass II
BR81532930007Agulha de Veress UltimateClass II
BR81532930002Cânulas Trocartes Purple SurgicalClass II
SAME0000000381SFDAA00022Purple Surgical Magnetic Mat

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