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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

S-04-Pro — Class I MDR by Oscimed SA

MD Atlas
Oscimed SA

EUDAMED last updated this device on Sep 12, 2023

S-04-Pro

764010492SOMNOFIT8U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oscimed SA
UDI-DI code: 07640104927020
Reference / catalog number: S-04-Pro

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Manufacturer information

Organization name: Oscimed SA
SRN: CH-MF-000009605
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

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

CW010
EUDAMED did not publish a description for this code.
CW030
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.
CW011
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: 07640104927020
Basic UDI-DI: 764010492SOMNOFIT8U
Reference / catalog number: S-04-Pro
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: Mandibular advancement device intended to prevent snoring and sleep apnea
Additional information URL: https://www.oscimedsa.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q03010299ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER

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