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

0020302700 — IVDR Class B IVDR by Biokit S.A.

MD Atlas
Biokit S.A.

EUDAMED last updated this device on Oct 8, 2025

0020302700

8426950584971AK

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Biokit S.A.
UDI-DI code: 08426950584971
Reference / catalog number: 0020302700

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

Related devices

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

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

CW010
EUDAMED did not publish a description for this code.
CW267
EUDAMED did not publish a description for this code.
CW266
EUDAMED did not publish a description for this code.
CW999
These reagents, except the Complex, contain less than 0.1% sodium azide that may form explosive azides in metal plumbing. Use proper disposal procedures.
CW999
Complex: Up to 2.2% of the mixture consists of component of unknown acute toxicity (oral, dermal, inhalation) for human health and unknown hazard to the aquatic environment.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08426950584971
Basic UDI-DI: 8426950584971AK
Reference / catalog number: 0020302700
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: HemosIL HIT-Ab(PF4-H)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103020615COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)

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