Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003637635

FEI Number

3003637635

Entity Name

Contract Medical International GmbH

City/State/Country

DRESDEN Saxony, DE

Establishment Address

Lauensteiner Strasse 37, DRESDEN Saxony 01277, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CONTRACT MEDICAL INTL. GMBH (Owner Number: 9049562)

Owner / Operator Contact Address

Lauensteiner Strasse 37, DRESDEN, DE-NOTA 01277, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100799

PMA Number

N/A

All Registered Proprietary Names

LimFlow V-Ceiver DuraSheath Introducer Sheath System Compass Guiding Introducer Sheath LimFlow ARC Fortress Guide Sheath Hemostasis Valve LimFlow System Fortress

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2023-03-14
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2018-12-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-12-19
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2023-03-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2021-05-05
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2021-05-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-08-16
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2023-08-16
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-08-26
QWN	Stent Graft, Infrapopliteal, Venous Arterialization	Unknown	Class 3	N/A	2023-10-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2011-05-13

Official Correspondent

Klara Safrankova

US Agent Details

Timothy Desaulniers Business: Heraeus Medical Components, LLC Email: tim.desaulniers@heraeus.com Phone: (612) 3252003

Related Public Records

Same Entity

CONTRACT MEDICAL INTL. GMBH

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
K213494	ABBOTT MEDICAL	Aveir Retrieval Catheter	2022-04-01
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

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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3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003637635. Last updated year: 2026. Please use registration number 3003637635 when referencing this establishment in official correspondence.