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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

QV011IT — Class I MDR by Millet Innovation

MD Atlas
Millet Innovation

EUDAMED last updated this device on Nov 27, 2024

QV011IT

366039600099BG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Millet Innovation
UDI-DI code: 03660396019832
Reference / catalog number: QV011IT

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Manufacturer information

Organization name: Millet Innovation
SRN: FR-MF-000004611
Manufacturer status: Active

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Critical warnings

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

CW030
For people with arteritis, phlebitis, diabetes, lower limb neuropathy or allergy to any of the components: ask a health professional for advice and then monitor your foot during use.
CW262
EUDAMED did not publish a description for this code.
CW011
Do not use on damaged skin

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: not provided
UDI-DI code: 03660396019832
Basic UDI-DI: 366039600099BG
Reference / catalog number: QV011IT
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: 36–38 MU161

EMDN nomenclature code(s)

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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.