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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

ASTRO — Class I MDR by Unikulma Oy

MD Atlas
Unikulma Oy

EUDAMED last updated this device on Jul 19, 2023

ASTRO

643002415ASTY6C

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Unikulma Oy
UDI-DI code: 06430024151015
Reference / catalog number: ASTRO

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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: 06430024151015
Basic UDI-DI: 643002415ASTY6C
Reference / catalog number: ASTRO
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: Yksilöllisesti säätöpaloilla säädettävä Astro ergonominen tyyny on kehitetty tukemaan niskan oikeaa asentoa. Niskan oikea asento vähentää nikamiin ja lihaksiin kohdistuvaa rasitusta sekä parantaa niska-hartiaseudun verenkiertoa. Lisäksi niskan oikea asento avartaa hengitysteitä, mikä tuo apua kuorsauksesta kärsiville. Tyynyn profiloitu pinta takaa erinomaisen pintapehmeyden sekä ilmavuuden. Astro ergonomisen tyynyn sisus on viskoelastista polyuretaanivaahtoa ja päällinen antibakteerinen Silverness-kangas (hopealanka).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y1899AIDS, FURNITURE AND HOME AIDS FOR PERSONS WITH DISABILITIES - OTHER
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

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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.