Norma Received Renewed ISO 13485:2016 Certificate

Norma Instruments Zrt. met the requirements of the ISO 13485:2016 certification at the latest ISO re-qualification audit.

After a highly accurate and exhaustive preparation implemented for the quality management standard for medical device manufacturers, one of the world’s leading certification companies, SGS certified Norma’s development, production and distribution processes.

The renewed ISO 13485:2016 certificate is available here.

Important Note to Partners: Bank Account Change

Norma Instrument Zrt.’s bank account numbers have changed.

Our current MagNet bank accounts will be terminated to the 5th of April 2021.

Our new bank details with Sopron Bank Burgenland are the following:

BANK NAME: Sopron Bank Burgenland Zrt.

BANK ADDRESS: Budapest II. fiók, 1023 Bp., Lajos u.4-6.

SWIFT CODE: EHBBHUHS

(EUR) IBAN number

HU68 1760 0200 0095 9667 1020 0005

(USD) IBAN number

HU81 1760 0200 0095 9667 3020 0007

(HUF) 

Bank account number for HUF: 17600200-00959667-00200004

IBAN number for HUF: HU13 1760 0200 0095 9667 0020 0004

Correspondent Bank details for both accounts:

BANK NAME : Raiffeisen Bank

SWIFT CODE (for Correspondent Bank): RZBAATWW

Please, kindly use these bank details for all your future payments to Norma Instruments.

Kind regards, 

The Norma Team

Norma Icon-3 hematology analyzers were donated in Kenya

The governments of Hungary and the Republic of Slovenia have implemented a joint healthcare assistance project in Kenya donating three Norma Icon-3 hematology analyzers among 44 state-of-the-art medical instruments to hospitals.

The University of Nairobi-Kenyatta National Hospital, the National Spinal Injury Referral Hospital and the Kericho County Referral Hospital will use the Norma Icon-3, a smart and small 3-diff hematology analyzer. The instruments will contribute to fight against Covid-19 and help patients to receive faster diagnosis and treatment of other diseases such as malaria or HIV.

“Together with Prime Health Pharma our local distributor in Kenya, we are a proud partner of this joint development cooperation initiative of the Hungarian and Slovenian government. Norma is committed to develop small and smart hematology analyzers that can be used in point-of-care or near-patient testing environments all over the world” – claimed Gergely Domonkos Horváth, CEO of Norma Instruments Zrt. after the donation ceremony at Kericho County Referral Hospital in Kenya.

Important Note to Partners: Norma Office Holiday Closure

Norma Instruments’ office will be closed for seasons holidays from December 23, 2020 to January 4, 2021

During this time, no deliveries can be dispatched and no orders can be processed.

So if your company have orders planned to be still received in 2020,
we kindly ask you to send us your firm POs
at your earliest possible convenience to make sure they can be processed on time.

Orders will be processed on a “first come, first served” principle.
Thank you, in advance for your kind consideration.

Kind regards,
The Norma Team

Elevated red blood cell distribution width (RDW) is associated with the risk of Covid-19 mortality

During this Coronavirus crisis, all the attention of clinicians around the world lays on the direct diagnosis of the COVID-19 disease, whether by PCR, Rapid Tests or classical serology. However, cell blood counting contributes importantly to the proper diagnosis of any kind of viral or bacterial infections.

Furthermore, it has been found and scientifically described that the determination of specific parameters, such like the NLR (http://normadiagnostika.com/new-nlr-parameter-battle-covid-19-available-now) gives clinicians additional pieces of information about the eventual course of the disease in a COVID-19 infected patient.

Most recently, another work of the Massachusetts General Hospital (USA) has been published and has attracted the attention of clinicians around the world. It has been found that “an elevated red blood cell distribution width (RDW, a component of complete blood counts that reflects cellular volume variation), at the time of hospital admission and an increase in RDW during hospitalization were associated with increased mortality risk for patients with COVID-19”.

The study is based on a total of 1.641 patients with COVID-19 who received treatment at 4 hospitals in a large academic medical center network.

Please use the following link to get more details about this publication, which has been published on September 23rd on the Jama Network Open. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2770945

RDW is a standard parameter on all Norma CBC analyzers.

New NLR parameter to battle COVID-19 is available now!

The newly emerged coronavirus is affecting all us now and we hope that you and your families are safe and will stay safe throughout the pandemic. Norma is dedicated to contribute and help to this still growing and sadly, worsening virus outbreak that is threatening many of our lives all around the world. For this reason, our R&D Team have introduced a new parameter in our Icon-5 and Icon-5 OP analyzers, the NLR, which is short for Neutrophil-to-Lymphocyte Ratio.

Based on multiple evaluations*, NLR was found to be the most significant factor affecting the severe illness incidence of patients who were diagnosed positive for COVID-19. These studies concluded that the age of the patient and the NLR value can be an early indication on the severity progress of the disease. This is important because it can provide a foresight to doctors who can make early estimations and preparations for the course and treatment of their patient, thus helping them to focus on the more severe cases or cases that will turn severe in the upcoming days.

It is important to note that:

  • the NLR value alone is not sufficient for coronavirus screening;
  • the NLR parameter alone is not capable of indicating the current status or future course of the disease of healthy or asymptomatic virus infected individuals;
  • the NRL parameter alone cannot be used to give diagnosis and/or treatment and cannot by itself provide a basis for assessing or deciding on a patient’s condition.

Norma’s Point-of-Care hematology analyzers with the new NLR parameter can be an excellent tool to help doctors at the front line of the epidemic:

  • CBC results can be obtained at site, thus helping them with quicker diagnosis;
  • Quicker diagnosis reduces referral time, thus helping patients to receive treatment faster;
  • Faster treatment leads to faster emission or transfer time, thus helping to provide a more efficient patient care.

The new NLR software is available on our website’s internal support section.

If you are interested in the new NLR parameter or our analyzers in general, please contact area sales managers for more information:
http://normadiagnostika.com/contact-us.

*References:

Norma receives Environmental Innovation Prize!

We are proud to announce that Norma has received the Environmental Innovation Prize 2018 for its Icon hematology product family.

The Environmental Innovation Prize and other six innovation awards including the Innovation Grand Prize are given to those Hungarian based companies who achieved significant business benefits through outstanding technical and economical innovation performance in the year preceding the award ceremony.

The 27th Innovation Grand Prize was organized by the Hungarian Association for Innovation with close collaboration with the National Research, Development and Innovation Office, the Ministry of Agriculture and the Hungarian Intellectual Property Office. The award ceremony was held in the Hungarian Parliament on the 28th of March 2019, where Mr. Gergely Horváth, Norma’s Chief Executive Officer, received the award from Mr. Sándor Farkas, Parliamentary State Secretary, and Mr. Ádám Szigeti, Deputy State Secretary.

We are proud that our team’s creative effort to develop sustainable and environmentally friendly innovations was honored with such a prestigious award. These developments are contributing to the environmental protection and support a greener future in many ways:

  • The analyzer’s small size
    • less material is used during manufacturing
    • less transportation-related emissions
  • The reagent consumption is reduced by 70% compared to other products on the market
    • less chemicals used
    • less water consumption
    • less transportation-related emissions
    • less biohazardous waste is produced
  • Possibility of electronic data management through LIS, Ethernet, and USB connections
    • less paper is used by end users.

We will continue our unique innovations and developments to build a better future.

Photos: Boltresz Attila, Feith Sándor

Hungarian Association for Innovation:
https://www.innovacio.hu/

Press Release:
Átadták a 2018. évi Innovációs Nagydíjakat (ORIGO)

Norma launches the only retrofittable Autoloader available on the market

Norma’s hematology product portfolio is continuously expanding. Norma’s newest hematology accessory, the Norma Autoloader is an automatic sample vial loading device that allows better workflow and improved time efficiency for your laboratory.

Besides its space-saving dimensions similar to any Icon’s compact size, what makes the Autoloader a unique instrument is that it is the only retrofittable autosampler on the IVD market; it can simply connected via USB to existing Icon-5 hematology analyzers.

Norma Autoloader’s unique features like it’s moving robotic arm, sample vial gripper operation, built-in sample mixer and barcode reader together with the 2 interchangeable sample trays, each with a 50-vial sample capacity, makes it perfect to help your laboratory’s continuous workflow.

All these great features make the Icon-5 more suitable for medium and big laboratories.

For more information and technical specifications:
http://normadiagnostika.com/accessories/norma-autoloader

The Icon-5 OP is now available!

Norma is proud to announce that its hematology family has grown again, and a new, laser-based 5-part diff analyzer has been added to its hematology product portfolio, the Icon-5 OP.

The Icon-5 OP inherited all the Icon-5’s best features, such as its compact size, straightforward navigation, elegant design and maintenance free operation. The Icon-5 OP also kept its predecessor’s cost-effectiveness because of its extremely low reagent consumption. The difference between the two analyzers is in their sampling mode; while users could only perform closed tube measurements with the Icon-5 thus far, the Icon-5 OP now gives users an opportunity for open tube sampling, which also allows them to measure from capillary samples.

The Icon-5 OP, similar to other Icon analyzers, was primarily developed to be used in Point-of-Care or near-patient testing environments, such as in Intensive Care Units, Emergency Departments, GP Offices, Blood Banks or even in Mobile Care Units, allowing patients to receive faster diagnosis and treatment, thus helping them with more efficient and faster recovery.

For more information and specification, please visit the Icon-5 OP’s product page:

Icon-5 OP

Norma receives the new ISO 13485:2016 Certificate

Norma is proud to announce that the company’s ISO 13485 re-certification audit was successful!

After 13 years, the 2003 revision was replaced by the new ISO 13485:2016, which was the basis for our audit. Hence, the successful re-qualification does not only mean that Norma could maintain its comprehensive quality management system throughout the years, but it could improve, and it now complies with the new global regulatory requirements as well.

Thank you for everyone’s hard work and contribution for making this happen!


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