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Oasis Medical, Inc.

USA · Glendora

✓ 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

18listed device types

Class I 13Class II 1Class III 1unclassified 3

plus 46 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 2Class II 8

13 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

12active device licences

Class II 12

24 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

6device registrations

CLASS B 4CLASS C 1CLASS D 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

9active ARTG entries

Class I 3IIa 4IIb 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States46 registration records, 17 510(k), 0 PMA, 4 excluded

Brazil10 confirmed, 1 excluded

Canada12 confirmed, 0 excluded

Manufacturer names merged into this page: Oasis Medical, Inc. · OASIS MEDICAL, INC. · OASIS MEDICAL INC. · Oasis Medical · OASIS MEDICAL , INC

FDA 510(k) clearances by year

11991

11992

21994

41995

11998

12000

12001

22002

22003

12017

12022

FDA listed device types

showing 8 of 18

Marker, Skin 1Knife, Ophthalmic 1Surgical Eye Tray 1Forceps, General & Plastic Surgery 1Pack, Hot Or Cold, Disposable 1Collagen Corneal Shield 1Cannula, Ophthalmic 1Forceps, Ophthalmic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213988	SOFT PLUG Extended Duration 180 Tapered Canalicular Plug	2022-06-03
US	K162361	Soft Plug Extended Duration 180 Canalicular Plug	2017-04-17
US	K032297	DISPOSABLE N-PE MICKROKERATOME BLADES	2003-08-26
BR	80286920002	Espuma Cirúrgica em Lança Soft Cell	Class II
BR	80286920003	Espuma Cirúrgica Soft Cell	Class I
BR	80286920004	Expansor de Iris OASIS	Class II
CA	31519	MICROKERATOME BLADE - SINGLE USE	Class II
CA	31778	DISC FILTERS	Class II
CA	31780	TONO SHIELD TONOMETER SHIELDS	Class II

Oasis Medical, 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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