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

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

MD Atlas
R. Langenbrinck GmbH

EUDAMED last updated this device on May 16, 2026

08-0081/FE Set

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: 04262354731887
Reference / catalog number: 08-0081/FE Set

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: 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

Critical warnings

8 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.
CW313
EUDAMED did not publish a description for this code.
CW295
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	Jan 1, 2020	Dec 5, 2029

Device identification

Trade name: not provided
UDI-DI code: 04262354731887
Basic UDI-DI: 4262354TwstEW
Reference / catalog number: 08-0081/FE Set
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 50 ml half filled with 4% formaldehyde labeled with Institutslabel and IVD marking white screw cap mounted with suction insert in twist 100 ml
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
Serial number
Software identification

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.