Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

KDRK 390 — Class I MDR by WENDRE POLAND SPÓŁKA Z…

MD Atlas
WENDRE POLAND SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

EUDAMED last updated this device on Nov 4, 2025

KDRK 390

59049215KDRK390MZ

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: 05904921508285
Reference / catalog number: KDRK 390

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

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

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

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: not provided
UDI-DI code: 05904921508285
Basic UDI-DI: 59049215KDRK390MZ
Reference / catalog number: KDRK 390
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: Kołdra służy do zapewnienia odpowiedniej izolacji cieplnej, a dzięki puszystemu wypełnieniu zapewnia komfortowy sen poprzez odpowiednie dopasowanie do kształtu ciała. Kołdra wykonana 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: 220 x 200 cm

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05904921508285

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

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

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

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

Y1899AIDS, FURNITURE AND HOME AIDS FOR PERSONS WITH DISABILITIES - 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

Become a partner of MD Atlas

Related devices

Aloe Vera orthopedic pillow59049215POSATWOn the market Aloe Vera orthopedic pillow59049215POSATWOn the market Antibacterial duvet 160 x 200 cm59049215KASH233KXOn the market Antibacterial duvet 220 x 200 cm59049215KASH233KXOn the market Antibacterial pillow 70 x 80 cm59049215PASH44MDOn the market

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.