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

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Organization name
UDI-DI code
Reference / catalog number

Wright-Giemsa JetDye-AF — IVDR Class A IVDR

MD Atlas
Bio-Gram Diagnostics GmbH

EUDAMED last updated this device on Mar 2, 2026

Wright-Giemsa JetDye-AF

426240002JetDyeKE

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Bio-Gram Diagnostics GmbH
UDI-DI code: 04262400020224
Reference / catalog number: RG2209022

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Manufacturer information

Organization name: Bio-Gram Diagnostics GmbH
SRN: DE-MF-000032559
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: Wright-Giemsa JetDye-AF
UDI-DI code: 04262400020224
Basic UDI-DI: 426240002JetDyeKE
Reference / catalog number: RG2209022
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: Wright-Giemsa JetDye-AF solution is used for human-medical cell diagnosis and serves the hematological and histological investigation of sample material of human origin. The staining solution makes target structures of cells evaluable for diagnostic purposes in human-hematological and histological specimen materials, for example smears of whole blood. The images created using the staining solutions support the professional user to define the form and structure of compartments of cells.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103010302ROMANOWSKY STAINS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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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.