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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

FYN ELBOW — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Dec 2, 2025

FYN ELBOW

37014598MACG3D002STK4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03701459811410
Reference / catalog number: FYN ELBOW

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Manufacturer information

Organization name: GROUPE SOBER SAS
SRN: FR-MF-000017818
Manufacturer status: Active

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

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

CW018
Consulter la notice d’utilisation

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: FYN ELBOW
UDI-DI code: 03701459811410
Basic UDI-DI: 37014598MACG3D002STK4
Reference / catalog number: FYN ELBOW
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: L’orthèse FYN ELBOW est une immobilisation orthopédique entièrement fabriquée en impression 3D. Cette orthèse est composée de PLA ou acide polylactique, issue d'amidon maïs, matière biosourcée et biodégradable. Cette orthèse se présente sous forme de gouttière alvéolée permettant, après avoir été chauffée, de former une gouttière à 90° allant du bras à la main du patient. Les fermetures se font à l’aide de rubans accrocheurs. Il n’y a pas de compression pour le patient et le praticien peut ajuster l’orthèse en fonction de l’œdème du patient. Lors de la pose de l’orthèse sur le patient, et pour éviter toute brulure ou lésions cutanées, un jersey (non fournit) devra obligatoirement être utilisé. Attelles fabriquées en France
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: TXXS - Ambidextre - Longueur avant-bras 20-24cm

EMDN nomenclature code(s)

Y060619ELBOW-WRIST-HAND ORTHOSES

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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