Organization name

EXBIO Praha, a.s.

SRN

CZ-MF-000033468

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW267

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• CW032

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• CW119

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• CW076

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• CW082

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• CW083

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• CW085

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• CW087

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• CW090

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• CW093

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• CW094

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• CW100

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• CW102

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• CW137

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• CW158

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• CW167

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• CW313

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• CW148

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Primary placement in Czechia; available across 20 countries total.

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08594208060116

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

859420806ED775074

Reference / catalog number

ED7750

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Product Content: PNH High-Sensitivity Assay 25 pcs ED7750-1 PNH WBC 7-color ED7750-2 PNH RBC 3-color ED7750-3 Lysing Solution 1 pcs ED7750-4 PNH Compensation Set 1 pcs Reagent is sufficient for 25 tests.

Additional information URL

https://www.exbio.cz/clinical-products/hematology/kits/dryflowex-pnh-high-sensitivity-assay-kit

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0103080199MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER

• IVDR Class C medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.