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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

Anti-decubitus mattress — Class I MDR by Sairex Ky

MD Atlas
Sairex Ky

EUDAMED last updated this device on Dec 8, 2022

Anti-decubitus mattress

64298107684350XG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sairex Ky
UDI-DI code: 06429810768506
Reference / catalog number: 4350

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Manufacturer information

Organization name: Sairex Ky
SRN: FI-MF-000016116
Manufacturer status: Inactive

Market distribution

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: Anti-decubitus mattress
UDI-DI code: 06429810768506
Basic UDI-DI: 64298107684350XG
Reference / catalog number: 4350
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: A pad to be placed on top of a bed mattress. Lessens decubitus ulcers and pressure sores. Uppers plasticized fabric, to be wiped and removed for washing. Filling of viscoelastic foamed plastic (PU) is airy, elastic and heat retaining. Re-usable.
Additional information URL: https://verkkokauppa.sairex.fi/
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

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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.