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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

AW OXC001 5.S — Class IIa MDR by Awatar Medical Aid d.o.o.

MD Atlas
Awatar Medical Aid d.o.o.

EUDAMED last updated this device on May 13, 2026

AW OXC001 5.S

385889357AWOX0016J

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Awatar Medical Aid d.o.o.
UDI-DI code: 03858893574750
Reference / catalog number: AW OXC001 5.S

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Manufacturer information

Organization name: Awatar Medical Aid d.o.o.
SRN: HR-MF-000025777
Manufacturer status: Active

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Market distribution

Primary placement in Croatia; available across 1 country total.

Country	On market since	Until
CroatiaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03858893574750
Basic UDI-DI: 385889357AWOX0016J
Reference / catalog number: AW OXC001 5.S
Issuing entity: GS1

Classification

Risk category: Class IIa
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.

EMDN nomenclature code(s)

Z12159004OXYGEN CONCENTRATORS

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.