GREINER BIO-ONE HUNGARY KFT

FDA Device Registration & Listing · MOSONMAGYAROVAR Gyor-Moson-Sopron, HU · Registration 3003997691

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
3003997691
FEI Number
3003997691
Entity Name
GREINER BIO-ONE HUNGARY KFT
City/State/Country
MOSONMAGYAROVAR Gyor-Moson-Sopron, HU
Establishment Address
FERTOSOR 7, MOSONMAGYAROVAR Gyor-Moson-Sopron H-9200, HU
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
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
N/A
PMA Number
N/A

All Registered Proprietary Names

VACUETTE Urine Beaker MiniCollect Carrier Tubes Vacuette Urine Beaker with Integrated Transfer Device VACUETTE Urine Transfer Device MiniCollect Funnel Blood Transfer Unit Vacuette No Additive Urine Tubes VACUETTE No Additive Tubes VACUETTE Sample Transfer Unit Vacuette Urine STB tubes

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2008-09-17

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
3007817041 GREINER BIO-ONE GMBH Rainbach im Muehlkreis Oberosterreich, AT
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003997691. Last updated year: 2026. Please use registration number 3003997691 when referencing this establishment in official correspondence.
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