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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

Kit 8 Pieces 1xChemise Op XL… — Class I MDR by CA Diffusion

MD Atlas
CA Diffusion

EUDAMED last updated this device on Nov 20, 2025

Kit 8 Pieces 1xChemise Op XL 1xCharlotte 1xPeignoir 1xPantalon XL 2xCouvres Chaussures 2xMules XL

376006117KITPATIENT7R

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CA Diffusion
UDI-DI code: 03760061177611
Reference / catalog number: KIT61XL_F

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Manufacturer information

Organization name: CA Diffusion
SRN: FR-MF-000012222
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.

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: Kit 8 Pieces 1xChemise Op XL 1xCharlotte 1xPeignoir 1xPantalon XL 2xCouvres Chaussures 2xMules XL
UDI-DI code: 03760061177611
Basic UDI-DI: 376006117KITPATIENT7R
Reference / catalog number: KIT61XL_F
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: Chemise Opéré (bleue) Totalement opaque, très douce, respirante et résistante, elle répond parfaitement aux exigences des équipes médicales et chirurgicales. Sa matière et sa confection sont étudiées pour plus de confort. Fermeture par lacet à la ceinture et au cou. Confection Cousue. Peignoir (bleu) ultra doux, respirante et résistante, fermeture par ceinture à la taille. Slip (bleu) jetable totalement opaque, très doux, maintien par un élastique encapsulé Charlotte clip (bleue), couvre-chaussures (blanches) et mules (blanches).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T020401STANDARD SURGICAL GOWNS
T0207CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
T0208SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)

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