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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

F006611004380 — Class I MDR by Health and Fashion…

MD Atlas
Health and Fashion Shoes Italia SpA

EUDAMED last updated this device on Sep 19, 2025

F006611004380

805714973BIOMECHANICSW4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Health and Fashion Shoes Italia SpA
UDI-DI code: 08052667003063
Reference / catalog number: F006611004380

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View device family (Basic UDI)

Manufacturer information

Organization name: Health and Fashion Shoes Italia SpA
SRN: IT-MF-000038685
Manufacturer status: Active

Related devices

MF312901019460805714973MEMORYCUSHIONB8On the market MF312901019430805714973MEMORYCUSHIONB8On the market MF312901040440805714973MEMORYCUSHIONB8On the market MF312901040430805714973MEMORYCUSHIONB8On the market MF312901019470805714973MEMORYCUSHIONB8On 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.

Critical warnings

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

CW267
PELLE SCAMOSCIATA SULLA TOMAIA
CW010
LIBRETTO

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08052667003063
Basic UDI-DI: 805714973BIOMECHANICSW4
Reference / catalog number: F006611004380
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: COLOR BLACK
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y063303READY-MADE ORTHOTIC SHOES
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

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