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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

TetaQuick — IVDD — General IVDD by AAZ PRODUCTIONS LE…

MD Atlas
AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL

EUDAMED last updated this device on Oct 11, 2024

TetaQuick

B-03770011742301

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
UDI-DI code: 03770011742301
Reference / catalog number: TR-TET-001

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Manufacturer information

Organization name: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
SRN: FR-MF-000015889
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: TetaQuick
UDI-DI code: 03770011742301
Basic UDI-DI: B-03770011742301
Reference / catalog number: TR-TET-001
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Rapid test for the qualitative detection of Clostridium tetani antibodies in blood (whole blood/serum/plasma) specimens, to determine tetanus immunity status 10 tests/kit.
Additional information URL: https://www.aazlab.fr/tetaquick/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105090106CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC

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

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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.