Identity
- Trade Name
- EM Disposable Stylet EUDAMED
- Device Name
- EM Disposable Stylet EUDAMED
- Model / Reference
- 18097-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056481004965 EUDAMED
- Basic UDI-DI
- 4056481EMStylet4C EUDAMED
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
EM Disposable Stylet by Brainlab SE — Class III — 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 | 4056481EMStylet4C | Class III | Active |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (1)
- EUDAMED adca471e-f93b-40f5-b11b-6442d22f1e00 61 fields · synced Jul 27, 2026