Identity
- Trade Name
- myoMOTION Charging Station EUDAMEDMyoMotion FDA UDI
- Generic Name
- Kinesiology/electromyographic sensor set FDA UDI
- Device Name
- Wireless IMU Family Accessories EUDAMEDMyoMotion Sensor Charging Station FDA UDI
- Model / Reference
- 613 EUDAMEDFDA UDI
- Description
- MyoMotion Sensor Charging Station FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816271020261 EUDAMEDFDA UDI
- Basic UDI-DI
- 081627102IMUACC5F EUDAMED
- Direct Marketing DI
- 00816271020261 EUDAMED
- FDA Product Code
- KQX FDA UDI
- EMDN Code
- Z12062580 KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Kinesiology/electromyographic sensor set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1500 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
No
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
myoMOTION Charging Station 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 | 081627102IMUACC5F | 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 54465f86-c5b3-428b-ac4e-4cc635365241 61 fields · synced Jun 18, 2026
- FDA UDI 2b7c875f-1332-456f-8936-a2f3830973da 35 fields · synced May 30, 2026