Identity
- Trade Name
- OptiStim EUDAMED
- Model / Reference
- OptiHair2 EUDAMEDOptiStim EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262355232192 EUDAMED
- Basic UDI-DI
- 426235523OptiHair28F EUDAMED
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
OptiStim by Mrc Systems Gmbh Medizintechnische Systeme — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 426235523OptiHair28F | Class I | Active |
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Manufacturer
- Manufacturer
- MRC Systems GmbH Medizintechnische Systeme
- EUDAMED SRN
- DE-MF-000011848
Sources (1)
- EUDAMED 19d75d71-9e5a-4247-a97a-8250f8ac4eab 61 fields · synced Jul 10, 2026