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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

ELAST — Class I MDR by Unikulma Oy

MD Atlas
Unikulma Oy

EUDAMED last updated this device on Jul 19, 2023

ELAST

643002415ELPA49

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Unikulma Oy
UDI-DI code: 06430024154412
Reference / catalog number: ELAST

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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: 06430024154412
Basic UDI-DI: 643002415ELPA49
Reference / catalog number: ELAST
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 astro patja on kehitetty pienentämään makuullaan olosta kehoon muodostuvaa pintapainetta ja siten ehkäisemään painehaavojen kehittymistä. Eliksiiri astro patja on erityisesti tarkoitettu käytettäväksi patjana tilanteissa, joissa joudutaan viettämään makuullaan pitkiä aikoja. Eliksiiri astro patjaa voidaan käyttää myös tavanomaisessa käytössä patjana lisäämään käyttäjien käyttömukavuutta.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080702NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

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 ELAOS643002415ELTY65On the market ELAOB643002415ELPA49On 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.