GREINER BIO-ONE GMBH

FDA Device Registration & Listing · Rainbach im Muehlkreis Oberosterreich, AT · Registration 3007817041

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
3007817041
FEI Number
3007817041
Entity Name
GREINER BIO-ONE GMBH
City/State/Country
Rainbach im Muehlkreis Oberosterreich, AT
Establishment Address
Gewerbepark 2, Rainbach im Muehlkreis Oberosterreich 4261, AT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GREINER BIO-ONE NA (Owner Number: 8020040)
Owner / Operator Contact Address
4238 Capital Drive, Monroe, NC 28110, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K173757
PMA Number
N/A

All Registered Proprietary Names

VACUETTE QUICKSHIELD Safety Tube Holder Vacuette Quickshield Complete PLUS Safety Tube Holder Vacuette Quickshield Complete Safety Tube Holder VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 1998-01-13
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2007-11-08
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-09-17
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2019-09-17

Official Correspondent

No official correspondent registered.

US Agent Details

Angela Drysdale Business: GREINER BIO-ONE NORTH AMERICA, INC. Email: angela.drysdale@gbo.com Phone: (704) 7768646

Related Public Records

Same Entity

GREINER BIO-ONE NA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003997691 GREINER BIO-ONE HUNGARY KFT MOSONMAGYAROVAR Gyor-Moson-Sopron, HU
3005674478 GREINER BIO ONE BRASIL PRODUTOS MEDICOS HOSPITALAR AMERICANA Sao Paulo, BR
8020040 GREINER BIO-ONE GMBH KREMSMUENSTER Oberosterreich, AT
1125230 GREINER BIO-ONE NORTH AMERICA, INC. MONROE, NC, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Similar Registrations

Registration Number Establishment Name Location
3027338968 RONCADELLE OPERATIONS SRL Castel Mella Brescia, IT
3000214934 ALMAC PHARMA SERVICES LLC Audubon, PA, US
3006850123 JAPAN IRRADIATION SERVICE CO., LTD Naka-gun Ibaraki, JP
3029328631 PEGASUS IMPORTS Houston, TX, US
3010621964 ATLAS MEDICAL PRODUCTS LLC Hialeah, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007817041. Last updated year: 2026. Please use registration number 3007817041 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.