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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

Semelles - Form'Vital — Class I MDR by NOAO SA

MD Atlas
NOAO SA

EUDAMED last updated this device on Dec 15, 2025

Semelles - Form'Vital

370176384908000HD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NOAO SA
UDI-DI code: 03701763800148
Reference / catalog number: BE4908

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Manufacturer information

Organization name: NOAO SA
SRN: FR-MF-000022232
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Do not apply to open wounds or wounds in the process of healing. Not intended for use in pregnant or breastfeeding women.

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: Semelles - Form'Vital
UDI-DI code: 03701763800148
Basic UDI-DI: 370176384908000HD
Reference / catalog number: BE4908
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: Semelles préfabriquées destinées à être adaptées par découpe afin de s’ajuster à la pointure de l’utilisateur. Dispositif médical non invasif destiné au soutien du pied.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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.