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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

4X.388-XL — Class I MDR by OrtoProfil Prod Romania…

MD Atlas
OrtoProfil Prod Romania SRL

EUDAMED last updated this device on May 22, 2026

4X.388-XL

5944784ORTMEMBRUINFOCSPKV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OrtoProfil Prod Romania SRL
UDI-DI code: 05944784001721
Reference / catalog number: 4X.388-XL

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Manufacturer information

Organization name: OrtoProfil Prod Romania SRL
SRN: RO-MF-000000526
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05944784001721
Basic UDI-DI: 5944784ORTMEMBRUINFOCSPKV
Reference / catalog number: 4X.388-XL
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: Dispozitivul medical este destinat exclusiv pentru tratamentul următoarelor indicații: Hallux valgus nivel incipient și moderat, previne suprapunerea/deformarea degetelor învecinate.Compoziție/caracteristici: este confecționat din material textil elastic cu închidere prin sistem velcro pentru corectarea deviației în valg al degetului mare de la picior (Hallux valgus). A se poziționa astfel încât susținerea/corecția segmentului anatomic să fie optimă - mărime XL
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.