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

Norma-iRP52 OP — IVDR Class A IVDR by NORMA Instruments…

MD Atlas
NORMA Instruments Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on May 20, 2026

Norma-iRP52 OP

59991062iRP5OPC2

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: 05999106200108
Reference / catalog number: IC-91772

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

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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement		Still on market

Device identification

Trade name: Norma-iRP52 OP
UDI-DI code: 05999106200108
Basic UDI-DI: 59991062iRP5OPC2
Reference / catalog number: IC-91772
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: Norma-iRP52 OP is a dedicated set of reagents intended to be used with Icon-5 OP semi-automated hematology analyzers. The reagent pack contains the following reagents: iDil5 OP (3400 mL), iLyse5 OP (1000 mL), iClean5 OP (1150 mL). [250 tests]
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103010105CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

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