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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

SK2209202 — IVDR Class A IVDR by Bio-Gram Diagnostics GmbH

MD Atlas
Bio-Gram Diagnostics GmbH

EUDAMED last updated this device on Mar 9, 2026

SK2209202

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: 04262400022020
Reference / catalog number: SK2209202

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Manufacturer information

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

Critical warnings

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

CW129
Contains Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate. May produce allergic reaction.

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: not provided
UDI-DI code: 04262400022020
Basic UDI-DI: 426240002JetDyeKE
Reference / catalog number: SK2209202
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: JetDye-AF are staining reagents for manual and automated staining of blood smears prior microscopic analyses for In-vitro-Diagnostic use. Contains besides the MGG JetDye-AF Kit, JetBuffer pH 6.8 and JaClean, required for system application (CJN).
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

Batch number
Expiration date
Manufacturing date
Serial number
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.