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PIXXGEN Corporation

www.pixxgen.com

✓ Record-verifiedregistrations found in 3 marketsEU SRN KR-MF-000013581

This company has registrations in European Union, United States, Brazil — 3 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

3UDI-DI device records

Class IIa 3

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 3 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

2registered devices

Class I 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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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.

European Union3 raw hits, 0 excluded, 3 confirmed

United States3 registration records, 4 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: PixxGen Corporation · PIXXGEN CORPORATION

Regulatory identity

EU manufacturer SRN: KR-MF-000013581
EU authorised representative: CMC Medical Devices & Drugs SL
Exhibition record: CMEF 93rd (Apr 2026, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809378240245	Prudent 1212	Class IIa
EU	08809378240207	Prudent 1417	Class IIa
EU	08809378240191	Prudent 1717	Class IIa
US	K211108	Prudent 1717, Prudent 1417, Prudent 1212	2021-06-04
US	K190691	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
US	K182533	PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels	2018-10-04
BR	10332510018	Familia de Digitalizador de Imagens - Novomedica	Class I
BR	10332510020	PIXX WI-FI	Class I

PIXXGEN Corporation

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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