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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

KH 34 — Class I MDR by AMW NAWROT SPÓŁKA…

MD Atlas
AMW NAWROT SPÓŁKA KOMANDYTOWA

EUDAMED last updated this device on Oct 20, 2025

KH 34

59076660KOLHEL68A5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AMW NAWROT SPÓŁKA KOMANDYTOWA
UDI-DI code: 05907666009895
Reference / catalog number: KH 34

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View device family (Basic UDI)

Manufacturer information

Organization name: AMW NAWROT SPÓŁKA KOMANDYTOWA
SRN: PL-MF-000025355
Manufacturer status: Active

Related devices

KH 3259076660KOLHEL68A5On the market KH 3059076660KOLHEL68A5On the market KH 3459076660KOLHEL68A5On the market KH 3359076660KOLHEL68A5On the market KH 3059076660KOLHEL68A5On 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.

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.

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

Device identification

Trade name: not provided
UDI-DI code: 05907666009895
Basic UDI-DI: 59076660KOLHEL68A5
Reference / catalog number: KH 34
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 poprzez odpowiednie dopasowanie do kształtu ciała użytkownika zapewnia odpowiednią izolację cieplną podczas odpoczynku i snu. Wyrób wykonany jest z materiałów barierowych, które zmniejszają ryzyko rozwoju roztoczy kurzu domowego i ich alergenów kałowych, czyli głównego alergenu człowieka. 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: 160 MU10
200 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05907666009895

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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.

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

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