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Purple Surgical

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

15listed device types

Class I 9Class II 6Class III 0

plus 28 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

11 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

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 States28 registration records, 1 510(k), 0 PMA, 3 excluded

Brazil5 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: PURPLE SURGICAL INTERNATIONAL LIMITED · Purple Surgical Manufacturing Limited · PURPLE SURGICAL INTERNATIONAL LIMITED / PURPLE SURGICAL UK LIMITED · PURPLE SURGICAL INTERNATIONAL LTD. · PURPLE SURGICAL DO BRASIL LTDA · Purple Surgical

FDA 510(k) clearances by year

12014 · K142868

FDA listed device types

showing 8 of 15

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)

Market	Identifier	Name	Class / date
US	K142868	5mm 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 pin	2014-11-21
BR	82939369002	Agulha de Veress Ultimate	Class II
BR	81532930007	Agulha de Veress Ultimate	Class II
BR	81532930002	Cânulas Trocartes Purple Surgical	Class II
SA	ME0000000381SFDAA00022	Purple Surgical Magnetic Mat	—

Purple Surgical

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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