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Tecres S.P.A.

Italy · Sommacampagna

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel, Russia — 8 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

14510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class I 5Class II 6

22 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

17 including historic records

TWTaiwanTFDA

9valid device licences

Class II 8Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

32active ARTG entries

Class I 1Class III 13IIa 5IIb 7Class Im (measuring) 1Class Is (sterile) 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

2active registrations

Class 3 2

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 States0 registration records, 14 510(k), 0 PMA, 2 excluded

Brazil11 confirmed, 0 excluded

Manufacturer names merged into this page: TECRES S.P.A. · TECRES S.P.A

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252326	InterSpace GV Hip Spacer	2025-08-06
US	K211163	Bone Cement Genta, Bone Cement HV, Bone Cement LV	2023-01-09
US	K220131	KYPHON VuE Bone Cement	2022-04-18
BR	80102512818	PISTOLA PARA CIMENTO RALLY ALL IN ONE	Class I
BR	81000039025	Kit para Osteoplastia Mendec	Class II
BR	10242780058	APLICADOR GUN	Class I

Tecres S.P.A.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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