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BLUE ORTHO

France · Meylan Isere

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, South Korea, Australia — 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

4listed device types

Class I 1Class II 3Class III 0

plus 9 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class 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

1GMP quality-system certificates

Business type not stated 1

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IIa 3Class Is (sterile) 2

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 States9 registration records, 9 510(k), 0 PMA, 58 excluded

Brazil1 confirmed, 19 excluded

Saudi Arabia0 confirmed, 12 excluded

Canada0 confirmed, 7 excluded

Manufacturer names merged into this page: BLUE ORTHO · BLUE ORTHO (CHEMIN - MEYLAN)

FDA 510(k) clearances by year

12010

12016

22017

12020

22022

12023

12024

FDA listed device types

Orthopedic Stereotaxic Instrument 1System, Image Processing, Radiological 1Neurological Stereotaxic Instrument 1System, Digital Image Communications, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233299	ExactechGPS® System	2024-01-26
US	K232521	ExactechGPS® Total Ankle Application	2023-11-16
US	K213877	ExactechGPS® System	2022-05-02
BR	80102519105	Sistema para Auxiliar em Cirurgias Ortopédicas	Class II

BLUE ORTHO

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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