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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-bedsore seat for wheelchair… — Class I MDR

MD Atlas
Dr Sapporo Hanna Affelt Sp. j.

EUDAMED last updated this device on Nov 4, 2024

Anti-bedsore seat for wheelchair Ergo-Vent

5908249910ER3E6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr Sapporo Hanna Affelt Sp. j.
UDI-DI code: 59082499109422
Reference / catalog number: 5908249910942

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View device family (Basic UDI)

Manufacturer information

Organization name: Dr Sapporo Hanna Affelt Sp. j.
SRN: PL-MF-000044757
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: Anti-bedsore seat for wheelchair Ergo-Vent
UDI-DI code: 59082499109422
Basic UDI-DI: 5908249910ER3E6
Reference / catalog number: 5908249910942
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: An advanced orthopedic seat preventing pressure sores, featuring an innovative structure that ensures better ventilation. The product reduces pressure on sensitive body areas and supports air circulation, enhancing sitting comfort. Designed for long-term use.
Additional information URL: https://drsapporo.com/siedzisko-na-wozek-inwalidzki-ergo-vent,6-warstw
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)59082499109422

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Y122406BELTS, SEATS AND ARMRESTS FOR WHEELCHAIRS

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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