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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 Visiteur 5 Pieces 1xBlouse… — Class I MDR by CA Diffusion

MD Atlas
CA Diffusion

EUDAMED last updated this device on Nov 14, 2025

Kit Visiteur 5 Pieces 1xBlouse Pression PE 1xCharlotte 1xMasque Type II 2xCvres Chauss.

376006117KITPATIENTMASKLW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CA Diffusion
UDI-DI code: 03760061177949
Reference / catalog number: KIT521_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 Visiteur 5 Pieces 1xBlouse Pression PE 1xCharlotte 1xMasque Type II 2xCvres Chauss.
UDI-DI code: 03760061177949
Basic UDI-DI: 376006117KITPATIENTMASKLW
Reference / catalog number: KIT521_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: Blouse à usage unique pour la protection des visiteurs. Protection optimisée. Fermeture par pressions. Masque très Haute Filtration Type II 3 Plis à élastiques - bleu Charlotte clip, matière respirable. Couvre Chaussures bleu, élastique de maintien aux cheville, hydrofuge. Couleur: Blouse Blanc – Charlotte Blanche – Masque Bleu – Couvre Chaussure Blanche
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0208SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
T0207CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
T0205NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
T020604MEDICAL USE FACE MASKS, TYPE II AND IIR

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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