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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

Cupule bleue 90ml — Class I MDR by HEMODIA SAS

MD Atlas
HEMODIA SAS

EUDAMED last updated this device on Sep 3, 2024

Cupule bleue 90ml

3661379FAB0900001G6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HEMODIA SAS
UDI-DI code: 03661379254103
Reference / catalog number: 103739

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Manufacturer information

Organization name: HEMODIA SAS
SRN: FR-MF-000007191
Manufacturer status: Active

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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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Elles sont destinées à ne contenir qu'un liquide antiseptique ou du sérum physiologique. Elles ne sont pas destinées à contenir des dispositifs implantables, des préparations injectables, des médicaments destinés à être injectés ou des liquides invasifs Ne pas utiliser des produits incompatibles Les graduations n'ont pas de fonction de mesurage, elles ne donnent qu'une indication de volume

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: Cupule bleue 90ml
UDI-DI code: 03661379254103
Basic UDI-DI: 3661379FAB0900001G6
Reference / catalog number: 103739
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: La cupule est un petit récipient, utilisé dans le but de contenir un liquide antiseptique, du sérum physiologique, certains instruments médicaux ou pour la collecte de déchets biologiques La graduation présente sur la cupule est donnée à titre indicatif. La cupule ne doit pas être considérée comme un instrument de mesure
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 90 MU48
bleue

EMDN nomenclature code(s)

V0499CLINICAL USE CONTAINERS (NON-IVD) - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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Expiration date
Manufacturing date
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Software identification