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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

RO15 — Class I MDR by DIA-MED Egészségügyi és…

MD Atlas
DIA-MED Egészségügyi és Gépészeti Berendezéseket Gyártó és Forgalmazó Kft.

EUDAMED last updated this device on Dec 13, 2023

RO15

599957120RO00RS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DIA-MED Egészségügyi és Gépészeti Berendezéseket Gyártó és Forgalmazó Kft.
UDI-DI code: 05999571200054
Reference / catalog number: RO15

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Manufacturer information

Organization name: DIA-MED Egészségügyi és Gépészeti Berendezéseket Gyártó és Forgalmazó Kft.
SRN: HU-MF-000003115
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05999571200054
Basic UDI-DI: 599957120RO00RS
Reference / catalog number: RO15
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: —
Additional information URL: https://www.dia-med.hu/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080603TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS

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

Related devices

FK10599957120FK00NJOn the market FK10599957120FK00NJOn the market RO19599957120RO00RSOn the market VA12599957120VA00QGOn the market JK13599957120JK00PEOn 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.