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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

4T.S-200-EC-45 — Class I MDR by OrtoProfil Prod Romania…

MD Atlas
OrtoProfil Prod Romania SRL

EUDAMED last updated this device on May 28, 2026

4T.S-200-EC-45

5944784ORTMEMBRUINFOCSPKV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OrtoProfil Prod Romania SRL
UDI-DI code: 05944784003893
Reference / catalog number: 4T.S-200-EC-45

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Manufacturer information

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

Related devices

4X.388-XL5944784ORTMEMBRUINFOCSPKVOn the market 4T.S-200-PP-285944784ORTMEMBRUINFOCSPKVOn the market 4X.HM-26-05944784ORTPTCVCERVICOTO5NOn the market 4X.HM-26-I5944784ORTPTCVCERVICOTO5NOn the market 4X.HM-26-II5944784ORTPTCVCERVICOTO5NOn 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

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: 05944784003893
Basic UDI-DI: 5944784ORTMEMBRUINFOCSPKV
Reference / catalog number: 4T.S-200-EC-45
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 asigură în mod optim susţinerea şi corecţia modificărilor statice (picior plat, prăbuşirea boltei plantare longitudinale sau transversale). Se poate utiliza şi în tratarea clavusului sau a pintenului câlcânean, cât şi pentru prevenirea formării “degetului-ciocan” și nu în ultimul rând pentru confort și în susținerea performanțelor sportive. Orteza trebuie utilizată conform indicațiilor de specialitate - pentru exostoza calcaniană mărime 45
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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