Identity
- Trade Name
- UltraStim EUDAMED
- Device Name
- Neurostimulation Electrodes EUDAMED
- Model / Reference
- Neurostimulation Electrodes EUDAMEDSA1004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00856817005987 EUDAMED
- Basic UDI-DI
- 00851913006StimWT EUDAMED
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
UltraStim by Axelgaard Manufacturing Co., Ltd. — 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 | 00851913006StimWT | Class I | Active |
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Manufacturer
- Manufacturer
- Axelgaard Manufacturing Co., Ltd.
- EUDAMED SRN
- US-MF-000009382
- Authorised Representative
- Axelgaard Manufacturing Co., Ltd. DK-AR-000002096
Sources (1)
- EUDAMED 353886df-02df-4afa-8001-c8ac6996477a 61 fields · synced May 29, 2026