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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

RheelaxX — Class I MDR by YAER SARL

MD Atlas
YAER SARL

EUDAMED last updated this device on Mar 20, 2025

RheelaxX

3770029747RHEA4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: YAER SARL
UDI-DI code: 03770029747015
Reference / catalog number: 3770029747015

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Manufacturer information

Organization name: YAER SARL
SRN: FR-MF-000045665
Manufacturer status: Active

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: RheelaxX
UDI-DI code: 03770029747015
Basic UDI-DI: 3770029747RHEA4
Reference / catalog number: 3770029747015
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: Semelle RheelaxX taille L-XL beige
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

Related devices

RheelaxX3770029747RHEA4On the market RheelaxX3770029747RHEA4On the market RheelaxX3770029747RHEA4On the market

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.