MEDI-GLOBE GMBH

FDA Device Registration & Listing · VELEN North Rhine-Westphalia, DE · Registration 3011146996

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
3011146996
FEI Number
3011146996
Entity Name
MEDI-GLOBE GMBH
City/State/Country
VELEN North Rhine-Westphalia, DE
Establishment Address
LOGISTICS CENTER, SUDRING 21, VELEN North Rhine-Westphalia 46342, DE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
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
PMA Number
N/A

All Registered Proprietary Names

ClickTip Injectra SonoTip Pro and Pro Flex EBUS-TBNA Needle System Orbit-Snare RotaSnare SonoTip II Clear View Pro Control Vizeon

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-11-12
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2014-05-22
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2007-11-12
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 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
3004129994 MEDI-GLOBE SRO HRANICE Olomouc, CZ
9680809 MEDI-GLOBE GMBH Achenmuhle, Germany Bavaria, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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-0020-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4720

Similar Registrations

Registration Number Establishment Name Location
3008040402 Olympus Vietnam Co. Ltd. Dong Nai City, VN
1647149 Steritec Services, LLC ATHENS, TX, US
1056129 ENDO-THERAPEUTICS, INC. CLEARWATER, FL, US
3013526170 Jiangsu Vedkang Medical Science and Technology Co.,Ltd. Changzhou Jiangsu, CN
3003790304 GYRUS ACMI, INC. Westborough, MA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011146996. Last updated year: 2026. Please use registration number 3011146996 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.