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Paragon Medical Corporation

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, United Kingdom, Saudi Arabia, 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

0UDI-DI device records

USUnited StatesFDA openFDA

156listed device types

Class I 53Class II 96Class III 4unclassified 3

plus 428 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class I 2

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

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 States428 registration records, 6 510(k), 0 PMA, 16 excluded

United Kingdom2 confirmed, 3 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: Paragon Medical Inc. · PARAGON MEDICAL, INC. · Paragon Medical Device (Changzhou) Co., Ltd. · Paragon Medical - Mansfield, Bridgemedica · Paragon Medical, Inc.

Regulatory identity

UK responsible person: Emergo Consulting (UK) Limited

Business registration

Legal name: Paragon Medical, Inc.
LEI: 254900TUVTEQ9ILMOK64
Registration status: Active
Legal form: For-Profit Corporation (Corporation)
Registered address: 8 Matchett Industrial Park Drive, Pierceton, 46582
Registration authority: Business Services Division (Secretary of State), no. 1991060449
Registry record updated: 2022-05-05

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

FDA 510(k) clearances by year

11986 · K860022

12003 · K032119

12015 · K152951

12018 · K173615

22019 · K190667

FDA listed device types

showing 8 of 156

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Electrosurgical, Cutting & Coagulation & Accessories 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Cerclage, Fixation 1Washer, Bolt Nut 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	12143	Stryker Universal Select Sterilization Tray System	Class I
UK	12143	Advanced Imaging Modality (AIM) Sterilization Tray	Class I
US	K190667	Sonopet iQ Sterilization Tray	2019-06-13
US	K183701	Stryker ChestShield Sterilization Tray System	2019-05-07
US	K173615	Stryker Universal Select Sterilization Tray System	2018-04-18
SA	ME0000001798SFDAA00017	Sonopet iQ Sterilization Tray	—

Paragon Medical Corporation

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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