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Contract Medical International, GmbH

Germany · Dresden

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

16registered devices

Class II 16

17 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

1valid device licences

Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class III 1IIa 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 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 States26 registration records, 7 510(k), 0 PMA, 17 excluded

Brazil16 confirmed, 2 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 · Contract Medical Internetional GmbH (CMI)

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, GmbH

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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