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SUMMIT MEDICAL LIMITED

USA · Bourton-On-The-Water

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

49listed device types

Class I 33Class II 13Class III 0unclassified 3

plus 62 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 7Class II 10

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

5registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

15active device licences

Class II 13Class III 2

44 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

22active ARTG entries

Class I 11IIa 8IIb 3

HKHong KongMDACS

2valid listings

Class II 1Class III 1

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 States62 registration records, 20 510(k), 0 PMA, 29 excluded

Brazil17 confirmed, 0 excluded

Saudi Arabia5 confirmed, 0 excluded

Canada15 confirmed, 2 excluded

Manufacturer names merged into this page: SUMMIT MEDICAL LLC · SUMMIT MEDICAL LTD. · SUMMIT MEDICAL, INC. · SUMMIT MEDICAL PRODUCTS, INC. · SUMMIT MEDICAL, LLC · SUMMIT MEDICAL LIMITED

FDA 510(k) clearances by year

11995

22002

12003

32011

42014

42015

32017

22018

FDA listed device types

showing 8 of 49

Dispenser, Cement 1Clamp, Surgical, General & Plastic Surgery 1Speculum, Vaginal, Metal 1Tube, Ear Suction 1Stand, Infusion 1Cannula, Surgical, General & Plastic Surgery 1Splint, Intranasal Septal 1Punch, Biopsy, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180528	InstruSafe(R) Sterilization Container	2018-11-16
US	K173110	GRAFTSITE	2018-05-18
US	K162165	ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and ambIT Programmable Intermittent Pump	2017-08-29
BR	80537069002	Misturador de Cimento Ósseo - HiVac Bowl	Class II
BR	80537069003	Sistema de Mistura e Aplicação de cimento Ósseo - HiVac 7 & HiVac Syr	Class II
BR	80537069004	HiVac 7 com Pressurizador Femoral (Sistema de Mistura e distribuição d	Class II
SA	ME0000011525SFDAA00002	INSTRUSAFE	—
SA	ME0000011525SFDAA00003	TipVision	—
CA	86478	AMBIT PEELABLE SHEATH INTRODUCER	Class II
CA	86479	AMBIT TUNNELER	Class II
CA	101796	MICROI BLADE	Class II