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SYNERGETICS, INC.

USA · O'Fallon

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, 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

17listed device types

Class I 11Class II 6Class III 0

plus 24 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class II 11

12 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

9active device licences

Class II 7Class III 2

39 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

27active ARTG entries

Class I 14IIa 12IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 4Class 2b 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 States24 registration records, 18 510(k), 0 PMA

Brazil11 confirmed, 1 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: SYNERGETICS, INC. · SYNERGETICS INC

FDA 510(k) clearances by year

11992

11993

11994

11997

11998

11999

12001

12002

12003

22007

12009

12011

32012

12015

12016

FDA listed device types

showing 8 of 17

Pump, Infusion, Ophthalmic 1Instrument, Vitreous Aspiration And Cutting, Ac-Powered 1Apparatus, Cautery, Radiofrequency, Ac-Powered 1Photocoagulator And Accessories 1Endoilluminator 1Unit, Phacofragmentation 1Cannula, Trocar, Ophthalmic 1Knife, Ophthalmic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K160103	Spetzler Malis Dual Illuminating Bipolar Forceps	2016-10-12
US	K143123	Synergetics PHOTON EX	2015-02-24
US	K121426	AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS	2012-07-10
BR	80136060368	Cânulas de iluminação	Class II
BR	80136069016	Cabo de Instrumental para Microcirúrgia Oftalmológica	Class II
BR	80136069017	Pinças Microcirúrgicas Descartáveis - Synergetics	Class II
CA	10501	MALIS BIPOLAR COAGULATORS	Class III
CA	71726	MALIS SOLUTION IRRIGATION MODULE	Class II
CA	71827	MALIS INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET	Class II

SYNERGETICS, INC.

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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