Identity
- Trade Name
- OptiHair2 1mN EUDAMED
- Model / Reference
- OptiHair2 EUDAMEDOptiHair2 1mN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262355232000 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
OptiHair2 1mN by Mrc Systems Gmbh Medizintechnische Systeme — Class I — 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 | 426235523OptiHair28F | Class I | Active |
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Manufacturer
- Manufacturer
- MRC Systems GmbH Medizintechnische Systeme
- EUDAMED SRN
- DE-MF-000011848
Sources (1)
- EUDAMED b1f1cdf1-eab1-407d-b834-69fcd3bd7912 61 fields · synced Jul 8, 2026