Identity
- Trade Name
- Ultium EMG Sensor EUDAMEDUltium FDA UDI
- Generic Name
- Kinesiology/electromyographic sensor set FDA UDI
- Device Name
- Wireless EMG Family EUDAMEDUltium EMG Sensor FDA UDI
- Model / Reference
- 810 EUDAMEDFDA UDI
- Description
- Ultium EMG Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816271020223 EUDAMEDFDA UDI
- Basic UDI-DI
- 081627102EMGC7 EUDAMED
- Direct Marketing DI
- 00816271020223 EUDAMED
- FDA Product Code
- HCC FDA UDI
- EMDN Code
- Z12100401 ELECTROMYOGRAPHS EUDAMED
- GMDN Term
- Kinesiology/electromyographic sensor set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Market of Registration
- Germany 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
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ultium EMG Sensor by Noraxon USA, Inc. — 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 | 081627102EMGC7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Noraxon USA, Inc.
- EUDAMED SRN
- US-MF-000003882
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED d92d4f8e-4797-4ff0-ad9d-aa1b8de3b3c7 61 fields · synced Sep 17, 2026
- FDA UDI bd919beb-2d85-4d68-9e7a-933dcda41707 35 fields · synced May 30, 2026