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CONTRACT MEDICAL INTERNATIONAL, SPOL. S R.O.

Czech Republic · Hradec Kralove Hradec Kralove

✓ Record-verifiedregistrations found in 4 markets

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

8listed device types

Class I 0Class II 7Class III 1

plus 26 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class II 11

12 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

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 States26 registration records, 7 510(k), 0 PMA, 17 excluded

Brazil11 confirmed, 3 excluded

Canada3 confirmed, 3 excluded

Manufacturer names merged into this page: CONTRACT MEDICAL INTERNATIONAL, SPOL. S R.O. · Contract Medical International GmbH · CONTRACT MEDICAL INTERNATIONAL, GMBH · CONTRACT MEDICAL INTERNATIONAL GMBH

FDA 510(k) clearances by year

12015

12016

12018

12020

12022

12024

12025

FDA listed device types

System, Applicator, Radionuclide, Remote-Controlled 1Valvulotome 1Device, Percutaneous Retrieval 1Dilator, Vessel, For Percutaneous Catheterization 1Catheter For Crossing Total Occlusions 1Probe, Thermodilution 1Introducer, Catheter 1Stent Graft, Infrapopliteal, Venous Arterialization 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250439	Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca	2025-03-16
US	K240957	Catapult Guide Sheath	2024-08-14
US	K221914	Catapult Guide Sheath	2022-07-29
BR	80224399004	BAINHA INTRODUTORA FORTRESS 7F (45 cm, 65 cm e 90 cm)	Class II
BR	80224399005	BAINHA INTRODUTORA FORTRESS 8F (45 cm, 65 cm e 90 cm)	Class II
BR	80224390288	BAINHA INTRODUTORA FORTRESS 5F (65 cm e 90 cm)	Class II
CA	83011	FORTRESS INTRODUCER SHEATH SYSTEM	Class II
CA	82443	MARROW COLLECTION SYSTEM	Class II
CA	96312	MRWIRE	Class II

CONTRACT MEDICAL INTERNATIONAL, SPOL. S R.O.

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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