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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

Crystal-Violete JetDye-AF — IVDR Class A IVDR

MD Atlas
Bio-Gram Diagnostics GmbH

EUDAMED last updated this device on Mar 2, 2026

Crystal-Violete JetDye-AF

426240002CVJetDye4S

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: 04262400020156
Reference / catalog number: RG2209015

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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: Crystal-Violete JetDye-AF
UDI-DI code: 04262400020156
Basic UDI-DI: 426240002CVJetDye4S
Reference / catalog number: RG2209015
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: Crystal-Violete JetDye-AF solution is used for the first staining step in the Gram Polychrom JetDye-AF Kit. The Kit is used for human-medical cell diagnosis and serves the bacteriological investigation of sample material of human origin. The staining solution makes target structures of bacteria evaluable for diagnostic purposes in human liquids and histological specimen materials, for example smears of blood, urine, chair, secretions, cerebrospinal fluid, swabs from skin, wounds or body cavities, biopsies, aspirates, or irrigations from regions deeper in the body. The images created using the staining solutions support the professional user to define the form and structure of Gram-positive and Gram-negative bacteria.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104010804STAINS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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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.