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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

ELAOS — Class I MDR by Unikulma Oy

MD Atlas
Unikulma Oy

EUDAMED last updated this device on Jul 19, 2023

ELAOS

643002415ELTY65

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Unikulma Oy
UDI-DI code: 06430024154450
Reference / catalog number: ELAOS

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Manufacturer information

Organization name: Unikulma Oy
SRN: FI-MF-000035016
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Dec 5, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06430024154450
Basic UDI-DI: 643002415ELTY65
Reference / catalog number: ELAOS
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: Eliksiiri a-o-s istuintyyny on kehitetty pienentämään istumisesta kehoon muodostuvaa pintapainetta ja siten ehkäisemään painehaavojen kehittymistä. Eliksiiri a-o-s istuintyynyt on tarkoitettu käytettäväksi kehon ja alustan välissä erityisesti pyörätuoleissa. Eliksiiri a-o-s istuintyynyt soveltuvat käytettäväksi myös muilla alustoilla, joilla joudutaan istumaan pitkiä aikoja.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y122406BELTS, SEATS AND ARMRESTS FOR WHEELCHAIRS
V080399MEDICAL CUSHIONS - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

ASTRO643002415ASTY6COn the market ELAOB643002415ELPA49On the market ELAST643002415ELPA49On the market ELIST643002415ELTY65On the market ELLONK643002415ELTY65On 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.