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Organization name
UDI-DI code
Reference / catalog number

PKL 109 — Class I MDR by WENDRE POLAND SPÓŁKA Z…

MD Atlas
WENDRE POLAND SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

EUDAMED last updated this device on Mar 31, 2026

PKL 109

59049215PKL2P

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: WENDRE POLAND SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
UDI-DI code: 05904921509367
Reference / catalog number: PKL 109

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View device family (Basic UDI)

Manufacturer information

Organization name: WENDRE POLAND SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
SRN: PL-MF-000025862
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

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05904921509367
Basic UDI-DI: 59049215PKL2P
Reference / catalog number: PKL 109
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: Poduszka służy do podtrzymywania głowy, a dzięki puszystemu wypełnieniu zapewnia komfortowy sen poprzez odpowiednie dopasowanie do kształtu głowy i szyi. Poduszka wykonana jest z poszycia z tkaniny poliestrowej i wypełnienia z włókna poliestrowego, czyli z materiałów stanowiących barierę przed rozwojem roztoczy kurzu domowego i ich alergenów kałowych. Wyrób może być stosowany wspomagająco w zapobieganiu i łagodzeniu przebiegu poniższych chorób alergicznych, jako jeden z elementów wielokierunkowego działania zmierzającego do ograniczenia ekspozycji na alergeny: alergiczny przewlekły nieżyt nosa, astma oskrzelowa, atopowe zapalenie skóry, innych chorób o podłożu alergicznym (np. zapalenie spojówek, zatok, krtani, gardła i migdałków podniebiennych).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 70 x 80 cm

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.

V080399MEDICAL CUSHIONS - 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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