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Organization name
UDI-DI code
Reference / catalog number

Anatomical office chair Seiza — Class I MDR by Onsen Sp. z o.o.

MD Atlas
Onsen Sp. z o.o.

EUDAMED last updated this device on Oct 24, 2024

Anatomical office chair Seiza

5905123515042XT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Onsen Sp. z o.o.
UDI-DI code: 59058686561762
Reference / catalog number: 5905868656176

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Manufacturer information

Organization name: Onsen Sp. z o.o.
SRN: PL-MF-000037523
Manufacturer status: Active

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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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: Anatomical office chair Seiza
UDI-DI code: 59058686561762
Basic UDI-DI: 5905123515042XT
Reference / catalog number: 5905868656176
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: The ergonomic Seiza chair is an innovative solution supporting the prevention and treatment of spine conditions. Its advanced design allows for height adjustment and seat angle tilt, enabling customization to the user's individual needs. This chair promotes proper posture, reducing muscle tension. It is perfect for offices, physiotherapy clinics, or long sitting sessions, providing comfort and back health.
Additional information URL: https://onsen.eu/krzeslo-biurowe-seiza
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y180999CHAIRS / POSTURE SYSTEMS / SEAT POSITIONING AIDS - 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

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