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Organization name
UDI-DI code
Reference / catalog number

Surchaussures Classic' Roses… — Class I MDR by VBI Sarl

MD Atlas
VBI Sarl

EUDAMED last updated this device on Jun 29, 2023

Surchaussures Classic' Roses Taille L - Carton de 400

3770019642SC-1xx4T

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VBI Sarl
UDI-DI code: 03760391020045
Reference / catalog number: SC-106-C400

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Manufacturer information

Organization name: VBI Sarl
SRN: FR-MF-000026295
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: Surchaussures Classic' Roses Taille L - Carton de 400
UDI-DI code: 03760391020045
Basic UDI-DI: 3770019642SC-1xx4T
Reference / catalog number: SC-106-C400
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: 400
Additional product description: —
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)

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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Software identification