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Organization name
UDI-DI code
Reference / catalog number

G0B2F2B008 — Class I MDR by Hilding Anders Polska…

MD Atlas
Hilding Anders Polska Sp. z o.o.

EUDAMED last updated this device on May 6, 2024

G0B2F2B008

5901595wady_postawyJS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hilding Anders Polska Sp. z o.o.
UDI-DI code: 05901595009643
Reference / catalog number: G0B2F2B008

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Manufacturer information

Organization name: Hilding Anders Polska Sp. z o.o.
SRN: PL-MF-000032133
Manufacturer status: Active

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: not provided
UDI-DI code: 05901595009643
Basic UDI-DI: 5901595wady_postawyJS
Reference / catalog number: G0B2F2B008
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: Fandango to materac dający mocne wsparcie. Stworzony z myślą o komforcie osób z problemami kręgosłupa, większą wagą lub preferujących sen na twardszym podłożu. Wkład zbudowany na bazie sprężyny kieszeniowej zapewnia doskonałą elastyczność punktową. Materac dopasowuje się łatwo do anatomicznej budowy ciała – kręgosłup zyskuje optymalne wsparcie, a mięśnie odpoczywają i regenerują się. Podwyższoną twardość zawdzięczamy warstwie filcu oraz kokosu, którego włókna łączy wewnątrz lateks. Takie rozwiązanie pozwala zachować bardzo dobrą sprężystość i elastyczność. Materac dostępny w antyalergicznym pokrowcu Medi-Cover z możliwością prania. Fandango to materac o właściwościach wspomagających proces rehabilitacji wad postawy.
Additional information URL: https://hilding.pl/produkt/materace-kieszeniowe/hilding-fandango/
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.

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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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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.