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Electrode Cable for Stimuplex® HNS 11/12
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 4892070Model Cable Stimuplex
Identity
- Trade Name
- Electrode Cable for Stimuplex® HNS 11/12 EUDAMED
- Device Name
- Electrode Cable for Stimuplex® HNS 11/12 EUDAMED
- Model / Reference
- Cable Stimuplex EUDAMED4892070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260166372342 EUDAMED
- Basic UDI-DI
- 4260166370204031001Z5 EUDAMED
- EMDN Code
- N010180 NEUROPHYSIOLOGY DEVICES - ACCESSORIES 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
Electrode Cable for Stimuplex® HNS 11/12 by Stockert GmbH — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003983 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 4260166370204031001Z5 | Class I | Active |
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Manufacturer
- Manufacturer
- Stockert GmbH
- EUDAMED SRN
- DE-MF-000006981
Sources (2)
- EUDAMED 662a4bea-d75f-438c-87b0-11bf66e37d1f 61 fields · synced Jun 18, 2026
- FDA 510(k) K003983 1 fields · synced May 18, 2026