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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

350112 — IVDR Class C IVDR by ANTITOXIN GmbH

MD Atlas
ANTITOXIN GmbH

EUDAMED last updated this device on Dec 2, 2024

350112

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: 04250861817682
Reference / catalog number: 350112

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Manufacturer information

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

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Dec 1, 2003	Still on market
Austria	Dec 1, 2003	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04250861817682
Basic UDI-DI: 4250861802.050KE
Reference / catalog number: 350112
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
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Software identification

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.

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