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ROHKEA™ VR Therapy
EUDAMEDClass IIa (EU MDR)
Ref ROHKEA™ VR Therapy
by Orion Oyj
Identity
- Device Name
- ROHKEA™ VR Therapy EUDAMED
- Model / Reference
- ROHKEA™ VR Therapy EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06432100120120 EUDAMED
- Basic UDI-DI
- 643210VRP00138 EUDAMED
- EMDN Code
- Z12069092 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ROHKEA™ VR Therapy by Orion Oyj — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 643210VRP00138 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Orion Oyj
- EUDAMED SRN
- FI-MF-000001595
Sources (1)
- EUDAMED 0fc606e7-5e72-4502-8259-f04c39db1ce7 61 fields · synced Jul 10, 2026