Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Wright-Giemsa JetDye-AF Kit — IVDR Class A IVDR

MD Atlas
Bio-Gram Diagnostics GmbH

EUDAMED last updated this device on Mar 2, 2026

Wright-Giemsa JetDye-AF Kit

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: 04262400020262
Reference / catalog number: RG2209026

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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: Wright-Giemsa JetDye-AF Kit
UDI-DI code: 04262400020262
Basic UDI-DI: 426240002JetDyeKE
Reference / catalog number: RG2209026
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.
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

Related devices

IVD2203103426240002CJN9KOn the market Crystal-Violete JetDye-AF426240002CVJetDye4SOn the market IVD2210104426240002EZMAOn the market RG2212071426240002FixESOn the market RG2211056426240002FixationZWOn the market

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.