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Stimuplex® HNS 12 System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 4892098Model Stimuplex® HNS 12 SystemRef 12970Model HNS-Stimulator
Identity
- Trade Name
- Stimuplex® HNS 12 System EUDAMEDStimuplex® HNS 12 EUDAMEDFDA UDI
- Generic Name
- Nerve-locating system FDA UDI
- Device Name
- Stimuplex® HNS 12 Nerv Stimulator with electrode cable / Electrode Cable Ordering-No. 4892070 FDA UDI
- Model / Reference
- Stimuplex® HNS 12 System EUDAMED4892098 EUDAMEDFDA UDIHNS-Stimulator EUDAMED12970 EUDAMED
- Description
- Stimuplex® HNS 12 Nerv Stimulator with electrode cable / Electrode Cable Ordering-No. 4892070 FDA UDI
Identifiers
- Catalog Number
- 4892098 FDA UDI
- Primary DI / UDI-DI
- 04260166372083 EUDAMEDFDA UDI04260166374056 EUDAMED
- Basic UDI-DI
- 426016637020703300139 EUDAMEDB-04260166374056 EUDAMED
- FDA Product Code
- BXN FDA UDI
- EMDN Code
- N010103 BIPOLAR NERVOUS ELECTROSTIMULATORS, BATTERY-POWERED EUDAMED
- GMDN Term
- Nerve-locating system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2775 FDA UDI
- Market of Registration
- Germany EUDAMED
- Medical Purpose
- System is intended for localisation of nerves. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Stimuplex® HNS 12 System by Stockert GmbH — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 426016637020703300139 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 426016637020703300139 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Stockert GmbH
- EUDAMED SRN
- DE-PR-000033120
Sources (3)
- EUDAMED 3f7b9e3f-8295-4307-8093-87a3f1397936 61 fields · synced Jun 20, 2026
- EUDAMED e3770245-7404-434a-9d32-7b50507544a2 61 fields · synced May 17, 2026
- FDA UDI 2673d6f0-632b-4c02-9785-820620353ed8 35 fields · synced May 30, 2026