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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

GEMINI ALPHA TAILLE 43 — Class I MDR by IMPLANTS SERVICE…

MD Atlas
IMPLANTS SERVICE ORTHOPEDIE

EUDAMED last updated this device on Dec 30, 2021

GEMINI ALPHA TAILLE 43

3615570GEMINIR2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: IMPLANTS SERVICE ORTHOPEDIE
UDI-DI code: 03615570000281
Reference / catalog number: GEMINI43A

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Manufacturer information

Organization name: IMPLANTS SERVICE ORTHOPEDIE
SRN: FR-MF-000000297
Manufacturer status: Active

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	May 25, 2021	Still on market
Belgium	May 25, 2021	Still on market

Device identification

Trade name: GEMINI ALPHA TAILLE 43
UDI-DI code: 03615570000281
Basic UDI-DI: 3615570GEMINIR2
Reference / catalog number: GEMINI43A
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y063303READY-MADE ORTHOTIC SHOES

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.

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