Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038188187

FEI Number

3038188187

Entity Name

CONTRACT MEDICAL INTERNATIONAL, SPOL. S R.O.

City/State/Country

Hradec Kralove, CZ

Establishment Address

Nachodska 811, Hradec Kralove 50301, CZ

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Contract Medical International, spol. s r.o. (Owner Number: 10093087)

Owner / Operator Contact Address

Nachodska 811, Hradec Kralove, CZ-521 50301, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Catapult Guide Sheath PiCCO Catheter LumenCare Catapult Guide Sheath Fortress Introducer Sheath System Comfort Catheter System Hemostasis Valve Fortress Introducer Sheath DuraSheath Introducer Sheath System Compass Guiding Introducer Sheath Picco Housing Vaginal CT/MR Multi Channel Applicator Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-08-26
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-08-26
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2026-03-25
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2026-01-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-08-26
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-08-26
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-08-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-08-26
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2026-01-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-08-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-08-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-03-28
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-03-28
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2026-03-25
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2026-01-28

Official Correspondent

Klara Safrankova

US Agent Details

Timothy Desaulniers Business: Heraeus Medevio Email: tim.desaulniers@heraeus.com Phone: (612) 3252003

Related Public Records

Same Entity

Contract Medical International, spol. s r.o.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

Similar Registrations

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3013764800	B. BRAUN MEDICAL INC.	Allentown, PA, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038188187. Last updated year: 2026. Please use registration number 3038188187 when referencing this establishment in official correspondence.