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

BG1421 — IVDR Class C IVDR by ANTITOXIN GmbH

MD Atlas
ANTITOXIN GmbH

EUDAMED last updated this device on Dec 2, 2024

BG1421

4250861802.050KE

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: ANTITOXIN GmbH
UDI-DI code: 04250861819259
Reference / catalog number: BG1421

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: ANTITOXIN GmbH
SRN: DE-MF-000008156
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Dec 1, 2003	Still on market
Germany	Dec 1, 2003	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04250861819259
Basic UDI-DI: 4250861802.050KE
Reference / catalog number: BG1421
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030399IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER

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

01.900-50-2B-04250861821276On the market 01.901-30-2B-04250861821283On the market 01.001-10B-04250861800110On the market 01.005-10B-04250861800318On the market 01.003-10B-04250861800219On 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.