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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

Orthopedic Pillow Hiro — Class I MDR by Onsen Sp. z o.o.

MD Atlas
Onsen Sp. z o.o.

EUDAMED last updated this device on Feb 11, 2025

Orthopedic Pillow Hiro

5905868656A02276

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Onsen Sp. z o.o.
UDI-DI code: 59058686568624
Reference / catalog number: 5905868656862

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View device family (Basic UDI)

Manufacturer information

Organization name: Onsen Sp. z o.o.
SRN: PL-MF-000037523
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: Orthopedic Pillow Hiro
UDI-DI code: 59058686568624
Basic UDI-DI: 5905868656A02276
Reference / catalog number: 5905868656862
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: The medical device is designed for use during sleep or rest. It is intended to position the head and cervical spine in a physiological position while sleeping on the side or back. It should not be used when sleeping on the stomach. It is dedicated to preventing the loss of cervical lordosis and supports the treatment and rehabilitation of existing spinal conditions. It promotes better body recovery during sleep. It minimizes the risk of muscle, joint, or bone pain, including that of the spine and surrounding structures. It should be used while sleeping on a bed.
Additional information URL: https://onsen.eu/poduszka-ortopedyczna-hiro,poszewka-purotex
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)59058686568624

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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.

V080302PATIENT POSITIONING MEDICAL CUSHIONS

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.