Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Hemolyzer® 5 NG automated 5-part… — IVDR Class A IVDR

MD Atlas
NORMA Instruments Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on Feb 6, 2024

Hemolyzer® 5 NG automated 5-part differential hematology analyzer with closed sampling method

59991062Icon5A6

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: NORMA Instruments Zártkörűen Működő Részvénytársaság
UDI-DI code: 05999106200429
Reference / catalog number: HE5100

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: NORMA Instruments Zártkörűen Működő Részvénytársaság
SRN: HU-MF-000014244
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW008
BIOHAZARD Risk of biological infection, contamination
CW013
LASER RADIATION Risk of exposure to laser radiation
CW999
WARNING Risk of personal injury

Market distribution

Primary placement in Hungary; available across 1 country total.

Placed on the market in Hungary; per-country availability dates not published.

Device identification

Trade name: Hemolyzer® 5 NG automated 5-part differential hematology analyzer with closed sampling method
UDI-DI code: 05999106200429
Basic UDI-DI: 59991062Icon5A6
Reference / catalog number: HE5100
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Hemolyzer 5 NG is a 60 tests/hour laser scattering and impedance-based IVD hematology analyzer for laboratory use, using specific reagents, performing 5-part differential analysis of 27 hematology parameters of anti-coagulated human whole blood samples introduced in closed vials.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202010101AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Autosampler NG accessory unit for automated sample vial loading59991062AutoloaderGHOn the market H3-Check Complete control blood set for 3-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials59991062NormaCont36BOn the market H3-Check Normal control blood set for 3-part differential Hemolyzer® hematology analyzers - 6 normal vials59991062NormaCont36BOn the market H3-Compact 10059991062iRP36POn the market H3-Compact 50059991062iRP36POn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.