Identity
- Trade Name
- Home tDCS EUDAMED
- Device Name
- EPTE SYSTEM EUDAMED
- Model / Reference
- EPTEV01V01 EUDAMEDEPTEV01DEV02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437023158043 EUDAMED
- Basic UDI-DI
- 8437023158EPTEV01LN EUDAMED
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Category: Point aesthesiometer
Home tDCS by Ionclinics & Deionic, S.l. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Point aesthesiometer.
- 3mm Standard Ball Tip Stimulating Probe — Rhythmlink International, LLC · Class IIa
- The PINPRICK — MRC SYSTEMS GmbH Medizintechnische Systeme · Class I
- ECOR — ElectroCore, Inc. · Class IIa
- PinPrick PP07 128mN — MRC SYSTEMS GMBH MEDIZINTECHNISCHE SYSTEME · Class I
- The PINPRICK — MRC SYSTEMS GmbH Medizintechnische Systeme · Class I
- PinPrick PP07 32mN — MRC SYSTEMS GMBH MEDIZINTECHNISCHE SYSTEME · Class I
- PLEXYGON — VYGON ITALIA SRL · Class IIa
- The PINPRICK — MRC SYSTEMS GmbH Medizintechnische Systeme · Class I
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 | 8437023158EPTEV01LN | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ionclinics & Deionic, S.l.
- EUDAMED SRN
- ES-MF-000020207
Sources (1)
- EUDAMED e2862af5-387b-4ca5-9dea-2f9f58cda221 61 fields · synced Jul 14, 2026