Identity
- Trade Name
- OptiHair2 8mN EUDAMED
- Model / Reference
- OptiHair2 EUDAMEDOptiHair2 8mN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262355232031 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 8mN 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 f23361c7-9ca9-4932-9153-72ee049f4893 61 fields · synced Jul 9, 2026