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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

SURCHAUSSURES CP+PE — Class I MDR by MONDIALISTO

MD Atlas
MONDIALISTO

EUDAMED last updated this device on Jan 17, 2024

SURCHAUSSURES CP+PE

37603539901643A

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MONDIALISTO
UDI-DI code: 03760353990188
Reference / catalog number: CLEAN-SHOE-CP+PE-50

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Manufacturer information

Organization name: MONDIALISTO
SRN: FR-MF-000013886
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: SURCHAUSSURES CP+PE
UDI-DI code: 03760353990188
Basic UDI-DI: 37603539901643A
Reference / catalog number: CLEAN-SHOE-CP+PE-50
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: 1000
Additional product description: Surchaussures de protection à usage unique en Polyéthylène chloré + Polyéthylène (CP+PE)
Additional information URL: https://www.mondialisto.com/
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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Expiration date
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Software identification