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TearScience, Inc.

USA · Milpitas

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong — 8 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

4listed device types

Class I 1Class II 3Class III 0

plus 5 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 3Class II 1

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

SASaudi ArabiaSFDA

6registered imported devices

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

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 2IIa 2

HKHong KongMDACS

1valid listings

Class II 1

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 States5 registration records, 9 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Saudi Arabia6 confirmed, 0 excluded

Manufacturer names merged into this page: TearScience, Inc. · TEARSCIENCE, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192623	LipiFlow Thermal Pulsation System	2019-10-22
US	K182506	LipiScan Dynamic Meibomian Imager	2018-12-10
US	K161357	LipiFlow Thermal Pulsation System	2016-11-04
BR	80147060178	LipiFlow Thermal Pulsation System	Class II
BR	80147060176	LipiScan Dynamic Meibomian Imager	Class I
BR	80147060179	Meibomian Gland Evaluator	Class I
SA	ME0000019087SFDAA00001	LipiFlow Thermal Pulsion System Cable Kit	—
SA	ME0000019087SFDAA00003	LipiScan Dynamic Meibomian Imager	—

TearScience, 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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