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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

BF070/L — Class I MDR by PHYTO PERFORMANCE…

MD Atlas
PHYTO PERFORMANCE ITALIA SRL

EUDAMED last updated this device on May 28, 2026

BF070/L

80312550016JZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PHYTO PERFORMANCE ITALIA SRL
UDI-DI code: 08031255038007
Reference / catalog number: BF070/L

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View device family (Basic UDI)

Manufacturer information

Organization name: PHYTO PERFORMANCE ITALIA SRL
SRN: IT-MF-000008118
Manufacturer status: Active

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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

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08031255038007
Basic UDI-DI: 80312550016JZ
Reference / catalog number: BF070/L
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: 2
Additional product description: BioFamily silicone heel supports with stabilizing walls, thanks to the high viscosity-elasticity damps loading points when walking and standing. Unlike current heel supports, this new and revolutionary silicone jelly distributes body loads evenly. Ideal for those who spend many hours a day walking or standing. It can be worn with any kind of shoes: classic and sport shoes. Reusable. Hand washable with a mild detergent. Let it dry before using it again in your shoes. Available in 2 sizes: M (37-39) e L (40-43) This model has been especially studied for people suffering from heel pain and rachialgia. This package contains 2 heel supports.
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)

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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