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

CK 321 — IVDD — General IVDD by Diaglobal GmbH

MD Atlas
Diaglobal GmbH

EUDAMED last updated this device on Jul 10, 2025

CK 321

B-4260152490074SM

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Diaglobal GmbH
UDI-DI code: D-4260152490074SM
Reference / catalog number: CK 321

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: Diaglobal GmbH
SRN: DE-MF-000032608
Manufacturer status: Active

Related devices

BilirubinB-4260152490067SQOn the market Bilirubin controlB-4260152490180SMOn the market CholesterolB-4260152490197T6On the market Creatine kinase in serum/plasmaB-4260152490586TMOn the market CreatinineB-4260152490302SBOn 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.

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: D-4260152490074SM
Basic UDI-DI: B-4260152490074SM
Reference / catalog number: CK 321
Issuing entity: EUDAMED

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: Reagenz zur Bestimmung von CK (Creatinkinase) im Blut, Serum, Plasma
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01010113CREATINE KINASE - TOTAL

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