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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

CH SPU 44x75 F10 1/3 PRED 2AD — Class I MDR by HEMODIA SAS

MD Atlas
HEMODIA SAS

EUDAMED last updated this device on Mar 5, 2024

CH SPU 44x75 F10 1/3 PRED 2AD

3661379FAB1000001D2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HEMODIA SAS
UDI-DI code: 03661379238035
Reference / catalog number: PS044016_A

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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.

CW009
EUDAMED did not publish a description for this code.

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: CH SPU 44x75 F10 1/3 PRED 2AD
UDI-DI code: 03661379238035
Basic UDI-DI: 3661379FAB1000001D2
Reference / catalog number: PS044016_A
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: Les champs ont pour but de limiter les infections lors du soin. Les champs sont des « draps » constitués d’un film imperméable et d’un substrat absorbant, laminés et collés ensemble. L’utilisation des champs de soins : permet la protection du patient afin de limiter le risque d’infection lors de la réalisation du soin, protège le patient des liquides et assure son confort pendant le soin. La fenêtre permet l’accès à la zone de soin tout en la protégeant de sa périphérie. La fente / prédécoupe se glisse autour d’une tubulure par exemple, afin de la protéger de sa périphérie tout en y donnant accès. L’adhésif permet de maintenir le champ.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 44 MU10
75 MU10

EMDN nomenclature code(s)

T020199SURGICAL DRAPES - 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
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Software identification