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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

IVD2210104 — IVDR Class A IVDR by Bio-Gram Diagnostics GmbH

MD Atlas
Bio-Gram Diagnostics GmbH

EUDAMED last updated this device on Mar 9, 2026

IVD2210104

426240002EZMA

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: 04262400021047
Reference / catalog number: IVD2210104

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Manufacturer information

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

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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.

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: 04262400021047
Basic UDI-DI: 426240002EZMA
Reference / catalog number: IVD2210104
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: Etzel I is an automated system for preparing sample smears on slides. For use by healthcare professionals on smearing human specimens 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)

W02069099VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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