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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

5133 — Class I MDR by OUSOFT SAS

MD Atlas
OUSOFT SAS

EUDAMED last updated this device on Oct 28, 2024

5133

3760339805133SONN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OUSOFT SAS
UDI-DI code: 37603398000054
Reference / catalog number: 5133

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Manufacturer information

Organization name: OUSOFT SAS
SRN: FR-MF-000044347
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW038
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: not provided
UDI-DI code: 37603398000054
Basic UDI-DI: 3760339805133SONN
Reference / catalog number: 5133
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: Le dispositif est destiné à aider à décoller les adhésifs de poches de stomie et à éliminer leur résidus de la peau
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 50 MU03

EMDN nomenclature code(s)

A108005DEVICES FOR THE REMOVAL OF ADHESIVES FROM THE PERISTOMAL SKIN

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

Related devices

This device is not currently linked to any other device.

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.