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SURGISTAR, INC.

USA · Vista

✓ 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

7listed device types

Class I 7Class II 0Class III 0

plus 6 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class II 11

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

10active device licences

Class II 10

15 including historic records

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

IIa 4Class Is (sterile) 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 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 States6 registration records, 4 510(k), 0 PMA

Brazil11 confirmed, 0 excluded

Canada10 confirmed, 0 excluded

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

FDA 510(k) clearances by year

11992 · K923689

11994 · K941747

11999 · K992978

12003 · K030891

FDA listed device types

Instrument, Surgical, Disposable 1Knife, Surgical 1Cannula, Ophthalmic 1Trephine, Manual, Ophthalmic 1Scalpel, One-Piece 1Needle, Aspiration And Injection, Disposable 1Cystotome 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K030891	SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK	2003-06-17
US	K992978	RICROKERATOME BLADE	1999-11-16
US	K941747	SURGISTAR TROCARS	1994-07-01
BR	80420200074	Trépano a Vácuo Surgistar	Class II
BR	80136060357	Bisturis Laseredge Plus	Class II
BR	10356500059	LÂMINA DE BISTURI COM CABO - SURGISTAR	Class II
CA	5473	CORNEAL TREPHINE	Class II
CA	6493	LENS MANIPULATOR	Class II
CA	7112	EYE WICK-PVA	Class II

SURGISTAR, 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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