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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

213 — Class I MDR by MAH OPORNICE Alojzija…

MD Atlas
MAH OPORNICE Alojzija Hrovat s.p.

EUDAMED last updated this device on May 28, 2026

213

383003616MAH15D

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MAH OPORNICE Alojzija Hrovat s.p.
UDI-DI code: 03830036162130
Reference / catalog number: 213

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View device family (Basic UDI)

Manufacturer information

Organization name: MAH OPORNICE Alojzija Hrovat s.p.
SRN: SI-MF-000045119
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Slovenia; available across 1 country total.

Country	On market since	Until
SloveniaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03830036162130
Basic UDI-DI: 383003616MAH15D
Reference / catalog number: 213
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: Opornica za roko – enostavna oblika
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 75x350 x1,5 [mm]

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.

Y060699ORTHOSES, UPPER EXTREMITY - OTHER

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.