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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

GIRO — Class I MDR by ALTER ÉCO SANTÉ SAS

MD Atlas
ALTER ÉCO SANTÉ SAS

EUDAMED last updated this device on Nov 3, 2022

GIRO

376031137PIVOTBR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ALTER ÉCO SANTÉ SAS
UDI-DI code: 03760311370243
Reference / catalog number: SIRO

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Manufacturer information

Organization name: ALTER ÉCO SANTÉ SAS
SRN: FR-MF-000003051
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

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

CW030
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 3 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Belgium		Still on market
Luxembourg		Still on market

Device identification

Trade name: GIRO
UDI-DI code: 03760311370243
Basic UDI-DI: 376031137PIVOTBR
Reference / catalog number: SIRO
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: Giro® est un appareil d’aide au transfert pour les personnes ayant des difficultés motrices des membres inférieurs. Grâce à sa base pivotante, solidaire d’un guidon de maintien et d’appuis tibiaux réglables en hauteur, en largeur et inclinables, il permet de réaliser rapidement un transfert assis-assis en toute sécurité avec l’aide d’un aidant. Grâce à son design étudié pour reproduire le schéma moteur naturel GIRO® est recommandé pour les soins, la toilette, le lever, le coucher d’un patient ayant la capacité à la station debout.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12019010PATIENT TRANSFER SYSTEMS

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

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Expiration date
Manufacturing date
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Software identification