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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 PLP — Class I MDD by MONDIALISTO

MD Atlas
MONDIALISTO

EUDAMED last updated this device on Jan 17, 2024

SURCHAUSSURES PLP

B-03760353990171

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: MONDIALISTO
UDI-DI code: 03760353990171
Reference / catalog number: CLEAN-SHOE-PP30-B

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Manufacturer information

Organization name: MONDIALISTO
SRN: FR-MF-000013886
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: SURCHAUSSURES PLP
UDI-DI code: 03760353990171
Basic UDI-DI: B-03760353990171
Reference / catalog number: CLEAN-SHOE-PP30-B
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Surchaussures à usage unique en polypropylène non tissé
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

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.