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UltraStim Dual
EUDAMEDFDA UDIClass I (EU MDR)
Ref ULB355Model Neurostimulation Electrodes
Identity
- Trade Name
- UltraStim Dual EUDAMEDFDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Neurostimulation Electrodes EUDAMED
- Model / Reference
- Neurostimulation Electrodes EUDAMEDULB355 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856817005802 EUDAMEDFDA UDI
- Basic UDI-DI
- 00851913006StimWT EUDAMED
- 510(k) Number
- K130987 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
UltraStim Dual by Axelgaard Manufacturing Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00851913006StimWT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 618146f7-ad28-40d0-ad09-e7276e41c3f4 61 fields · synced Jun 18, 2026
- FDA UDI f6b08aa6-28ad-4d8b-93d0-9b9a86a2c675 35 fields · synced May 30, 2026