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LABTICIAN OPHTHALMICS, INC.

Canada · Oakville

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Israel — 7 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

5listed device types

Class I 3Class II 2Class III 0

plus 5 registration records and 3 510(k), 1 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

11active device licences

Class II 7Class III 4

27 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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, 3 510(k), 1 PMA, 1 excluded

Canada11 confirmed, 0 excluded

Manufacturer names merged into this page: LABTICIAN OPHTHALMICS, INC. · LABTICIAN OPHTHALMICS INC. · LABTICIAN OPHTHALMICS INC

FDA 510(k) clearances by year

21999 · K990224

12000 · K000544

FDA listed device types

Weights, Eyelid, External 1Implant, Absorbable, (Scleral Buckling Methods) 1Kit, Surgical Instrument, Disposable 1Tape And Bandage, Adhesive 1Adaptor, Holder, Syringe 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K000544	BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080	2000-03-09
US	K990224	LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET	1999-04-12
US	K983607	LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS	1999-01-08
CA	6293	INFUSION CANNULA	Class II
CA	9813	SULFUR HEXAFLUORIDE GAS(SF6)	Class III
CA	13371	LABTICIAN C3F8 INTRAOCULAR GAS	Class III

LABTICIAN OPHTHALMICS, 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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