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

6K48-02 — IVDR Class C IVDR by Biokit S.A.

MD Atlas
Biokit S.A.

EUDAMED last updated this device on May 7, 2025

6K48-02

8436003070573XU

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Biokit S.A.
UDI-DI code: 00380740157531
Reference / catalog number: 6K48-02

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: Biokit S.A.
SRN: ES-MF-000002406
Manufacturer status: Active

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

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

CW116
EUDAMED did not publish a description for this code.
CW266
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: not provided
UDI-DI code: 00380740157531
Basic UDI-DI: 8436003070573XU
Reference / catalog number: 6K48-02
Issuing entity: GS1

Classification

Risk category: IVDR Class C
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Quantia Digitoxin Standard
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102080102DIGITOXIN

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

Related devices

01R08208436003070429XLOn the market 01R11108436003070610X9On the market 01R11228436003070610X9On the market 01R11018436003070610X9On the market 04R46168436003070641XLOn the market