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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

Lame Hopper Gamme PXL — Class I MDR by Hopper

MD Atlas
Hopper

EUDAMED last updated this device on Jan 22, 2024

Lame Hopper Gamme PXL

3770027689HL0127

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hopper
UDI-DI code: 03770027689102
Reference / catalog number: HL02PXL

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Manufacturer information

Organization name: Hopper
SRN: FR-MF-000024280
Manufacturer status: Active

Critical warnings

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

CW030
EUDAMED did not publish a description for this code.
CW022
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 2 countries total.

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

Device identification

Trade name: Lame Hopper Gamme PXL
UDI-DI code: 03770027689102
Basic UDI-DI: 3770027689HL0127
Reference / catalog number: HL02PXL
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: La lame de sport Hopper est un dispositif médical dédié aux amputés trans-tibiaux et trans-fémoraux souhaitant réaliser une activité physique de course à pied ou de randonnée. Ces personnes se doivent d’être équipées par un orthoprothésiste et d’avoir une prothèse adaptée. Ce dispositif configurable comprend 3 composants à assembler : une lame en composites équipée d’une accroche Velcro, un système de fixation métallique, une semelle. La lame de sport Hopper est disponible dans 2 modèles de tailles différentes et différentes gammes pour s’adapter au poids et à la pratique exercée par l’utilisateur. Le modèle de ce dispositif est Intrépide. La gamme de ce dispositif est PXL.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y062499LOWER EXTREMITY PROSTHESES - OTHER

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

Lame Hopper Gamme L3770027689HL0127On the market Lame Hopper Gamme M3770027689HL0127On the market Lame Hopper Gamme PL3770027689HL0127On the market Lame Hopper Gamme PM3770027689HL0127On the market Lame Hopper Gamme PS3770027689HL0127On 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.