MEDI-GLOBE SRO

FDA Device Registration & Listing · HRANICE Olomouc, CZ · Registration 3004129994

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004129994
FEI Number
3004129994
Entity Name
MEDI-GLOBE SRO
City/State/Country
HRANICE Olomouc, CZ
Establishment Address
OLOMOUCKA 306, HRANICE Olomouc 753 01, CZ
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
MEDI-GLOBE GMBH (Owner Number: 9011628)
Owner / Operator Contact Address
MEDI-GLOBE-STRASSE, 1-5, --, ACHENMUHLE, DE-BY D-83101, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Endoflux™ Biliary & Pancreatic Stent Sets SonoTip II Clear View Pro Control Vizeon ClickTip Injectra Optimizer Polyp Trap Clear View SonoTip II 25 gauge EUS needle Vizeon Pro Control Orbit-Snare RotaSnare

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2026-04-29
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2007-11-12
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-11-12
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2005-09-22
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2009-05-21
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2007-11-12

Official Correspondent

Stephan Schneider

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

MEDI-GLOBE GMBH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9680809 MEDI-GLOBE GMBH Achenmuhle, Germany Bavaria, DE
3011146996 MEDI-GLOBE GMBH VELEN North Rhine-Westphalia, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K902734 Olympus Corp. PR CANNULAS 1990-08-22
K150891 Covidien, LLC( Formerly Beacon Endoscopic Corp.) BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System 2015-05-01
K200745 United States Endoscopy Group, Inc. Lariat, Hot/Cold Snare 2020-04-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-05 N/A 2
Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011 Navilyst Medical, Inc 2
Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004129994. Last updated year: 2026. Please use registration number 3004129994 when referencing this establishment in official correspondence.
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