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PIXEE MEDICAL

France · Besancon Doubs

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Australia, Israel — 4 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 2Class II 3Class III 0

plus 8 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

11active ARTG entries

Class I 8IIa 1Class Im (measuring) 2

HKHong KongMDACS

pendingnot queried

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 States8 registration records, 7 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: PIXEE MEDICAL

FDA 510(k) clearances by year

12021 · K202750

22022 · K220104

12023 · K230789

12024 · K233899

12025 · K243975

12026 · K253805

FDA listed device types

Orthopedic Augmented Reality 1Endoscope, Neurological 1Laparoscope, General & Plastic Surgery 1Holder, Camera, Surgical 1Tray, Surgical, Instrument 1

Market	Identifier	Name	Class / date
US	K253805	Knee+	2026-04-24
US	K243975	Knee+	2025-03-20
US	K233899	Knee+	2024-03-08
BR	80102513289	Software Knee Plus	Class II
BR	80102513302	Kit Instrumental KneeTools	Class I

PIXEE MEDICAL

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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