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EUDAMED last updated this device on Nov 20, 2025
64298300954NE9TEFSim is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Peili Vision Oy. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06429830095439EFSim 2.0(01)06429830095439
European Medical Device Nomenclature — the EU product classification assigned to this device.
V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES3 warnings recorded — scroll inside the panel to see all entries.
Use of EFSim should not cause any unusual sensations, except for mild dizziness, nausea, headache, or fatigue. If the patient experiences side effects that are not part of normal use or are not mentioned here, stop using the application and contact Peili Vision as soon as possible.
The monitoring adult should consult healthcare professionals before use if the patient has any of the following conditions: ○ Diseases of the nervous system (ICD-10, G00–G99) ○ Mental and behavioral disorders due to psychoactive substance use (F10-F19) ○ Schizophrenia, schizotypal, and delusional disorders (F20-F29) ○ Acute severe depression or mania/hypomania (F30, F32, F33) ○ Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42) ○ Severe mental retardation (F72) ○ Disorders of psychological development (F80, F81, F83, F84) ○ Hearing or vision diagnoses (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness, and low vision)
Testing or related training should not be performed while standing. There is a risk of balance being disturbed and falling or colliding and which could result in injury.
Primary placement in Finland; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | May 26, 2025 | May 25, 2030 |
| Germany | Nov 1, 2025 | Oct 31, 2030 |
FI-MF-000007499FI25/0000006The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →This device is not currently linked to any other device.
Certificate health across this manufacturer's portfolio.
FI25/0000006SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →