Identity
- Trade Name
- Ybrain Inc. EUDAMED
- Device Name
- Transcranial Direct Current Stimulation device (MINDD) EUDAMED
- Model / Reference
- YDS-301N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800020401045 EUDAMED
- Basic UDI-DI
- B-08800020401045 EUDAMED
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Point aesthesiometer
Ybrain Inc. by Ybrain, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800020401045 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ybrain Inc.
- EUDAMED SRN
- KR-MF-000033358
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED da1716c0-a97e-4bf4-8250-98c28b7c349c 61 fields · synced Jul 10, 2026