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Medicrea International S.A.S. (Medtronic)

France · Rillieux-La-Pape

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

pendingnot queried

USUnited StatesFDA openFDA

31listed device types

Class I 17Class II 14Class III 0

plus 45 registration records and 48 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 7Class II 1

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

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.

United States45 registration records, 48 510(k), 0 PMA, 2 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: MEDICREA INTERNATIONAL · MEDICREA INTERNATIONAL S.A.S.

Same-named companies — This database also contains companies with near-identical names: Medicrea International, Inc., MEDICREA INTERNATIONAL S.A.S.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22011

22012

52013

22014

52015

82016

42017

42018

42019

12020

12021

52022

12024

22025

22026

FDA listed device types

showing 8 of 31

Screwdriver 1Instrument, Cutting, Orthopedic 1Template 1Reamer 1Wrench 1Probe 1Gauge, Depth 1Bit, Drill 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261374	LigaPASS System	2026-05-27
US	K261289	UNiD Spine Analyzer (SW3002)	2026-05-15
US	K253577	IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)	2025-12-19
BR	10314809013	KIT INSTRUMENTAL ALIF/ALIF-D-MEDICREA	Class I
BR	10314809012	KIT INSTRUMENTAL IMPIX-TLIF-MEDICREA	Class I
BR	10314809014	KIT DE INSTRUMENTAL PARA SISTEMA DE COLUNA PASS LP - MEDICREA	Class I

Medicrea International S.A.S. (Medtronic)

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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