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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

ELIST — Class I MDR by Unikulma Oy

MD Atlas
Unikulma Oy

EUDAMED last updated this device on Jul 19, 2023

ELIST

643002415ELTY65

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Unikulma Oy
UDI-DI code: 06430024154436
Reference / catalog number: ELIST

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Manufacturer information

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

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ASTRO643002415ASTY6COn the market ELAOS643002415ELTY65On the market ELAOB643002415ELPA49On the market ELAST643002415ELPA49On 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.

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: 06430024154436
Basic UDI-DI: 643002415ELTY65
Reference / catalog number: ELIST
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 istuintyyny on kehitetty käytettäväksi erilaisilla istuinalustoilla helpottamaan istumaan menemistä ja istumasta nousemista sekä parantamaan istuinmukavuutta.
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

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Expiration date
Manufacturing date
Serial number
Software identification