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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

Head Immobilizer EVA — Class I MDR by ROYAX, s.r.o.

MD Atlas
ROYAX, s.r.o.

EUDAMED last updated this device on Mar 17, 2026

Head Immobilizer EVA

859420820IMBSKB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ROYAX, s.r.o.
UDI-DI code: 08594208200093
Reference / catalog number: R-SI-HI-02

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Manufacturer information

Organization name: ROYAX, s.r.o.
SRN: CZ-MF-000020709
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.

Market distribution

Primary placement in Czechia; available across 1 country total.

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

Device identification

Trade name: Head Immobilizer EVA
UDI-DI code: 08594208200093
Basic UDI-DI: 859420820IMBSKB
Reference / catalog number: R-SI-HI-02
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 head immobilizer is intended to stabilize and secure the patient's head and cervical spine during emergency transport and immobilization procedures. The device is made of EVA foam blocks with adjustable straps and is used together with spine boards or stretchers.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0804PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.