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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

BORA MULE MED — Class I MDR by Health and Fashion…

MD Atlas
Health and Fashion Shoes Italia SpA

EUDAMED last updated this device on Feb 11, 2026

BORA MULE MED

805714973MEMORYCUSHIONB8

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: 08004373598463
Reference / catalog number: MF320802164400

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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

MF312901040400805714973MEMORYCUSHIONB8On the market MF312901040410805714973MEMORYCUSHIONB8On the market MF006251029470805714973MEMORYCUSHIONB8On the market MF006251029440805714973MEMORYCUSHIONB8On the market MF006251029430805714973MEMORYCUSHIONB8On 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

1 warning recorded — scroll inside the panel to see all entries.

CW267
FODERA + SOTTOPIEDE CON PELLE SCAMOSCIATA

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Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: BORA MULE MED
UDI-DI code: 08004373598463
Basic UDI-DI: 805714973MEMORYCUSHIONB8
Reference / catalog number: MF320802164400
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 ANTIQUE PINK
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.

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)
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

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