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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

08-0081/FX — IVDR Class A IVDR by R. Langenbrinck GmbH

MD Atlas
R. Langenbrinck GmbH

EUDAMED last updated this device on May 16, 2026

08-0081/FX

4262354TwstEW

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: R. Langenbrinck GmbH
UDI-DI code: 04262354732068
Reference / catalog number: 08-0081/FX

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Manufacturer information

Organization name: R. Langenbrinck GmbH
SRN: DE-MF-000025266
Manufacturer status: Active

Related devices

08-0015/E426235473PPS9On the market 08-0050/FX426235473Scinti4ROn the market 08-0050/FE426235473Scinti4ROn the market 08-0221/FE426235473PPS9On the market 08-0089/WFX426235473PPS9On 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.

Critical warnings

6 warnings recorded — scroll inside the panel to see all entries.

CW083
EUDAMED did not publish a description for this code.
CW093
EUDAMED did not publish a description for this code.
CW094
EUDAMED did not publish a description for this code.
CW159
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW148
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 12, 2026	Jan 1, 2029

Device identification

Trade name: not provided
UDI-DI code: 04262354732068
Basic UDI-DI: 4262354TwstEW
Reference / catalog number: 08-0081/FX
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: Twist Tube volume 20 ml half filled with 4% formaldehyde labeled with dangerlabel and IVD marking, with white screw cap
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05020103SAMPLES TRANSPORT, BOTTLES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification