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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

TROD'DENGUE — IVDD — General IVDD by AAZ PRODUCTIONS LE…

MD Atlas
AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL

EUDAMED last updated this device on Oct 11, 2024

TROD'DENGUE

B-03770011742660

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: 03770011742660
Reference / catalog number: TR-DEN-002

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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: TROD'DENGUE
UDI-DI code: 03770011742660
Basic UDI-DI: B-03770011742660
Reference / catalog number: TR-DEN-002
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 dengue virus NS1 antigen and IgM/IgG antibodies to dengue virus in blood (whole blood/serum/plasma) specimens, to aid in the diagnosis of dengue viral infections. 20 tests/kit.
Additional information URL: https://www.aazlab.fr/troddengue/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105040611DENGUE VIRUS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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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.