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Organization name
UDI-DI code
Reference / catalog number

H3-Check Normal control blood set… — IVDR Class A IVDR

MD Atlas
NORMA Instruments Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on Feb 8, 2024

H3-Check Normal control blood set for 3-part differential Hemolyzer® hematology analyzers - 6 normal vials

59991062NormaCont36B

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: 05999106200542
Reference / catalog number: HE3505

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Manufacturer information

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

Critical warnings

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

CW008
All body fluid samples should be considered potentially infectious materials. The product was tested negative against anti-HIV 1 and 2, antiHCV and HBsAg, but since no test method can rule out the danger of infection with absolute certainty, treat all blood and other potentially infectious materials with appropriate precautions. Use gloves, masks and gowns if blood exposure is anticipated.
CW011
For in vitro diagnostic use only. For trained laboratory professional only.

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: H3-Check Normal control blood set for 3-part differential Hemolyzer® hematology analyzers - 6 normal vials
UDI-DI code: 05999106200542
Basic UDI-DI: 59991062NormaCont36B
Reference / catalog number: HE3505
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: H3-Check Control Sets are intended for quality control measurements on the Analyticon hematology analyzer Hemolyzer® 3 NG (open and closed mode) (HE3100), and serve to validate the measurement results.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103010501NORMAL BLOOD CONTROLS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification

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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.