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Paragon Vision Sciences, Inc.

USA · Gilbert

✓ Record-verifiedregistrations found in 9 markets

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

5listed device types

Class I 0Class II 2Class III 2unclassified 1

plus 6 registration records and 16 510(k), 53 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

1active device licences

Class II 1

4 including historic records

TWTaiwanTFDA

2valid device licences

Class III 2

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

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 States6 registration records, 16 510(k), 53 PMA, 22 excluded

Brazil2 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 2 excluded

Manufacturer names merged into this page: Paragon Vision Sciences, Inc. · PARAGON VISION SCIENCES, INC. · PARAGON VISION SCIENCES INC.

FDA 510(k) clearances by year

11994

11998

31999

32000

12001

12002

12006

12007

12009

12012

12018

12023

FDA listed device types

Lens, Contact (Rigid Gas Permeable), Extended Wear 1Lens, Contact, Orthokeratology, Overnight 1Case, Contact Lens 1Lens, Contact (Other Material) - Daily 1Lens, Contact (Polymethylmethacrylate) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221768	Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses	2023-05-05
US	K180172	FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG	2018-03-16
US	K120996	FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN	2012-06-28
BR	80130439022	LENTES DE CONTATO PARAGON CRT	Class II
BR	80117580510	LENTES DE CONTATO PARAGON	Class II
CA	94377	PARAGON NORMALEYES	Class II

Paragon Vision Sciences, 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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