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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

Adapter mobile ancle — Class I MDR by SC ELITEX PROTHETIC SRL

MD Atlas
SC ELITEX PROTHETIC SRL

EUDAMED last updated this device on Jul 5, 2024

Adapter mobile ancle

5949096398ELPROBWZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SC ELITEX PROTHETIC SRL
UDI-DI code: 05949096398156
Reference / catalog number: OB20

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View device family (Basic UDI)

Manufacturer information

Organization name: SC ELITEX PROTHETIC SRL
SRN: RO-MF-000042662
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 Romania; available across 1 country total.

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

Device identification

Trade name: Adapter mobile ancle
UDI-DI code: 05949096398156
Basic UDI-DI: 5949096398ELPROBWZ
Reference / catalog number: OB20
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: Adaptoarele pentru picior protetic cu glezna mobila OB20 (oțel inoxidabil) conectează un picior protetic (OB11) la conectorul distal(ex. OB40,OB41,OB45…) al unei proteze modulare.Contine amortizorul din cauciuc, piulitele de fixare si semi bucsa distantier.. OB20=22-25 pentru Labe protetice de la 22 cm la 25 cm OB20=26-30 pentru Labe protetice de la 26 cm la 30 cm
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

UDI-DI DataMatrix

Encoded

(01)05949096398156

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y062409TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)
Y062415TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)

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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