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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

Salomon Sole Blue Fire — Class I MDR by Hopper

MD Atlas
Hopper

EUDAMED last updated this device on Nov 14, 2024

Salomon Sole Blue Fire

3770027689HL0127

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hopper
UDI-DI code: 03770027689119
Reference / catalog number: HS01B

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Manufacturer information

Organization name: Hopper
SRN: FR-MF-000024280
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: Salomon Sole Blue Fire
UDI-DI code: 03770027689119
Basic UDI-DI: 3770027689HL0127
Reference / catalog number: HS01B
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 semelle Salomon Blue Fire est destinée à être placée sur les lames Audacieuse by Hopper et Intrépide by Hopper pour assurer l'interface entre la lame et le sol en assurant une accroche adaptée pour la marche et la course à pied.
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.