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OCULO PLASTIK, INC.

Canada · Montreal

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia — 5 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

9listed device types

Class I 8Class II 1Class III 0

plus 9 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 8

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 III 10

16 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

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 States9 registration records, 14 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Canada10 confirmed, 0 excluded

Manufacturer names merged into this page: OCULO PLASTIK, INC. · OCULO-PLASTIK, INC. · OCULO-PLASTIK. INC · Óculo-Plastik Inc.

Business registration

Legal name: OCULO PLASTIK INC.
Corporation number: 2262142
Registration status: Active
Legal form: Canada Business Corporations Act
Incorporated: 1987-12-10
Registered address: 1170 EST, BOUL HENRI-BOURASSA, MONTREAL, QC, H2C 1G4

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11987

71990

11992

11994

12004

12008

12011

12013

FDA listed device types

showing 8 of 9

Wax, Dental, Intraoral 1Inserter/Remover Contact Lens 1Retractor 1Shield, Eye, Radiological 1Protector, Dental 1Tape, Measuring, Rulers And Calipers 1Clamp, Surgical, General & Plastic Surgery 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K123764	DURETTE OCULAR IMPLANT	2013-01-31
US	K112176	SILICONE SPHERES	2011-09-15
US	K073293	DURETTE IMPLANT	2008-03-19
BR	80153030047	PROTETORES OCULARES DE AÇO INOXIDÁVEL COX II E COX II H	Class I
BR	80153030042	PROTETORES OCULARES PLASTICOS	Class I
BR	80153039006	PROTETORES EXTERNOS DURETTE PLÁSTICOS	Class I
CA	11913	NEW ALLEN IMPLANT	Class III
CA	11940	COX MALAR EMINENCE IMPLANT	Class III
CA	12703	UNIVERSAL IMPLANT	Class III

OCULO PLASTIK, INC.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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