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Organization name
UDI-DI code
Reference / catalog number

ROHKEA™ VR Therapy — Class IIa MDR by Orion Oyj

MD Atlas
Orion Oyj

EUDAMED last updated this device on Mar 20, 2025

ROHKEA™ VR Therapy

643210VRP00138

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orion Oyj
UDI-DI code: 06432100120120
Reference / catalog number: ROHKEA™ VR Therapy

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Manufacturer information

Organization name: Orion Oyj
SRN: FI-MF-000001595
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
Read warnings and cautions before using the product.
CW999
Contra-indications: - The contraindication for the use of the product is age under 18 years. - History of epilepsy, migraine, vertigo or psychosis. - Treatment requiring motion sickness. - Pregnancy. - Severe or acute structural pathologies that the intervention (ROHKEA™ VR Therapy) could make worse, as assessed by a physician. - Psychotherapy in the previous 2 years or is currently receiving psychotherapy. - Condition that affects posture or balance.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 06432100120120
Basic UDI-DI: 643210VRP00138
Reference / catalog number: ROHKEA™ VR Therapy
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The intended purpose of the Rohkea™ VR Therapy is to provide an automated intervention based on cognitive behavioral therapy intended to help the subject overcome fear of movement. The device is intended for in-home use and to be assigned by health care professional. The product is intended to be used by competent adult (age ≥ 18 years) patients with fear of movement caused by chronic musculoskeletal pain.
Additional information URL: https://eifu.rohkea.health/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12069092VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

Certificate health across this manufacturer's portfolio.

CR-03-1230-861-24Supplemented
Quality management systemNotified body: 0537Expiry: Dec 22, 2028