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Organization name
UDI-DI code
Reference / catalog number

CH SPU 38x44 PLIE — Class I MDR by HEMODIA SAS

MD Atlas
HEMODIA SAS

EUDAMED last updated this device on Feb 14, 2024

CH SPU 38x44 PLIE

3661379FAB1000001D2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HEMODIA SAS
UDI-DI code: 03661379237298
Reference / catalog number: CPS380

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Manufacturer information

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

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 38x44 PLIE
UDI-DI code: 03661379237298
Basic UDI-DI: 3661379FAB1000001D2
Reference / catalog number: CPS380
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. La destination médicale revendiquée pour les champs est différente selon la nature du champ : champ de soins ou champ de table. 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. L’utilisation des champs de table : permet la protection de la zone de soins (telle qu’une table, un adaptable, le lit du patient ou tout autre support) dans le but de créer une surface de travail aseptique pour déposer les composants nécessaires au soin.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 44 MU10
38 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

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.