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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

OBALU — Class I MDR by Unikulma Oy

MD Atlas
Unikulma Oy

EUDAMED last updated this device on Jul 19, 2023

OBALU

643002415OBAL46

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Unikulma Oy
UDI-DI code: 06430024154467
Reference / catalog number: OBALU

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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: 06430024154467
Basic UDI-DI: 643002415OBAL46
Reference / catalog number: OBALU
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: Ortobed alustat ovat sähköisesti, joko langallisella tai langattomalla kaukosäätimellä säädettäviä rungollisia patja-alustoja. Ortobed alustalla saadaan vuodekokonaisuuden patja säädettyä moniin eri asentoihin, joilla saavutetaan useita suotuisia sekä lääketieteellisiä että terapeuttisia hyötyjä (ns. asentohoito). Ortobed alusta on suunnitelu lievittämään ja ehkäisemään tehokkaasti mm. kroonisia niska- ja selkäkipuja, ruoansulatusvaivoja, kuten närästystä sekä kuorsausta ja uniapneaa. Ortobed alustan käyttö tehostaa myös palautumista fyysisestä rasituksesta parantamalla kehon aineenvaihduntaa.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V08060101HOSPITAL/HOME CARE ELECTRIC 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

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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.