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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

Attelle de Poignet Ambidextre… — Class I MDR by MEDISPORT

MD Atlas
MEDISPORT

EUDAMED last updated this device on Apr 23, 2026

Attelle de Poignet Ambidextre X-Petit

3664617PGT02XX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDISPORT
UDI-DI code: 03664617004515
Reference / catalog number: PGT60.010

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Manufacturer information

Organization name: MEDISPORT
SRN: FR-MF-000000677
Manufacturer status: Active

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Critical warnings

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

CW030
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: Attelle de Poignet Ambidextre X-Petit
UDI-DI code: 03664617004515
Basic UDI-DI: 3664617PGT02XX
Reference / catalog number: PGT60.010
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 de poignet s’adapte aussi bien à la main droite qu’à la main gauche. Elle est composée de 3 baleines : 2 latérales et 1 palmaire. Mise en place facile grâce à l’encoche pour le pouce et la fermeture par bandes auto-agrippantes. Jersey coton de protection détachable permettant une mise à plat de l’orthèse (poignet oedemacié ou douloureux). Taille X-Petit
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060612WRIST-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

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.