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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

PDN-HLX.SX.L — Class I MDR by F.G.P. s.r.l.

MD Atlas
F.G.P. s.r.l.

EUDAMED last updated this device on Jun 9, 2025

PDN-HLX.SX.L

803348865Y06120301BT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: F.G.P. s.r.l.
UDI-DI code: 08052990117918
Reference / catalog number: PDN-HLX.SX.L

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View device family (Basic UDI)

Manufacturer information

Organization name: F.G.P. s.r.l.
SRN: IT-MF-000043862
Manufacturer status: Active

Related devices

2S-251V.XXL803348865Y06030801CJOn the market 2S-250V.XXL803348865Y06030801CJOn the market 2S-201V.XL803348865Y06030801CJOn the market 2S-251V.XL803348865Y06030801CJOn the market 2S-251V.L803348865Y06030801CJOn the market

Critical warnings

No critical warnings reported for this device.

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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: 08052990117918
Basic UDI-DI: 803348865Y06120301BT
Reference / catalog number: PDN-HLX.SX.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: 1
Additional product description: —
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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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.