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Codonics.Incorporated

USA · Middleburg Heights

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Australia, Israel, Russia — 6 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

6listed device types

Class I 4Class II 2Class III 0

plus 8 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 2a 1

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 States8 registration records, 8 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: CODONICS, INC. · Codonics Incorporated

FDA 510(k) clearances by year

11996

12001

12002

12003

12004

12006

12011

12025

FDA listed device types

Colorimeter, Photometer, Spectrophotometer For Clinical Use 1System, Digital Image Communications, Radiological 1Device, Digital Image Storage, Radiological 1Film, Radiographic 1Gas-Machine, Anesthesia 1Camera, Multi Format, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251352	Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)	2025-07-11
US	K101439	CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P	2011-02-07
US	K060440	CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER	2006-03-16
SA	ME0000009877SFDAA00001	VIRTUA	—

Codonics.Incorporated

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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