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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 35 — Class I MDR by IMPLANTS SERVICE…

MD Atlas
IMPLANTS SERVICE ORTHOPEDIE

EUDAMED last updated this device on Dec 30, 2021

GEMINI ALPHA TAILLE 35

3615570GEMINIR2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: IMPLANTS SERVICE ORTHOPEDIE
UDI-DI code: 03615570000175
Reference / catalog number: GEMINI35A

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Manufacturer information

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

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IGLOO ATTELLE DE RACHIS TAILLE M3615570IGLOOUSOn the market ANGEL'ICE3615570ANGELICETVOn the market ANGEL'ICE3615570ANGELICETVOn the market GEMINI ALPHA JEANS TAILLE 353615570GEMINIR2On the market GEMINI ALPHA JEANS TAILLE 363615570GEMINIR2On 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.

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 35
UDI-DI code: 03615570000175
Basic UDI-DI: 3615570GEMINIR2
Reference / catalog number: GEMINI35A
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
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Software identification