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Organization name
UDI-DI code
Reference / catalog number

Anti-decubitus cushion for chair — Class I MDR by Sairex Ky

MD Atlas
Sairex Ky

EUDAMED last updated this device on Dec 8, 2022

Anti-decubitus cushion for chair

64298107684355XS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sairex Ky
UDI-DI code: 06429810768537
Reference / catalog number: 4355

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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 cushion for chair
UDI-DI code: 06429810768537
Basic UDI-DI: 64298107684355XS
Reference / catalog number: 4355
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 chair cushion to lessen pressure sores. Protects also the chair material. Uppers plasticized fabric, to be wiped and removed for washing. Filling of viscoelastic foamed plastic (PU) is airy, elastic and heat retaining. The crotch stabilizes the occupants's sitting position. Plastic lock fastening. Re-usable.
Additional information URL: https://verkkokauppa.sairex.fi/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V08030102NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS

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.