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

TU1021.2 — IVDD — General IVDD by Immundiagnostik AG

MD Atlas
Immundiagnostik AG

EUDAMED last updated this device on May 19, 2026

TU1021.2

B-04050598007796

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Immundiagnostik AG
UDI-DI code: 04050598007796
Reference / catalog number: TU1021.2

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: Immundiagnostik AG
SRN: DE-MF-000020905
Manufacturer status: Active

Related devices

k 9401B-04050598005679On the market K 6923B-04050598000292On the market K 7735B-04050598000308On the market K 2112B-04050598121126On the market YM1000CAL1-64050598CMVITV2On 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

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

CW018
EUDAMED did not publish a description for this code.
CW074
EUDAMED did not publish a description for this code.
CW103
EUDAMED did not publish a description for this code.
CW104
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		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04050598007796
Basic UDI-DI: B-04050598007796
Reference / catalog number: TU1021.2
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: IDK® TurbiCAL® assay is a latex turbidimetric assay for the quantitative detection of calprotectin in human stool samples. IDK® TurbiCAL® is intended to exclusively differentiate between patients with inflammatory bowel disease (IBD) and patients with irritable bowel syndrome (IBS). This assay has a simple performance and multiple applications. This product is optimised for several automated analyser. For professional in vitro diagnostic use only.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102019009CALPROTECTIN

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