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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

02.053-02 — IVDD — Annex II List B IVDD by ANTITOXIN GmbH

MD Atlas
ANTITOXIN GmbH

EUDAMED last updated this device on Jan 18, 2025

02.053-02

B-04250861803210

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ANTITOXIN GmbH
UDI-DI code: 04250861803210
Reference / catalog number: 02.053-02

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Manufacturer information

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

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.

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: 04250861803210
Basic UDI-DI: B-04250861803210
Reference / catalog number: 02.053-02
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List B
Applicable legislation: IVDD [Directive 98/79/EC 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)

W0103030501OTHER ANTIGEN TYPING REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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