Identity
- Trade Name
- Clinical Sensor EUDAMEDMyoMotion FDA UDI
- Generic Name
- Kinesiology/electromyographic sensor set FDA UDI
- Device Name
- Wireless IMU Family EUDAMEDClinical Sensor FDA UDI
- Model / Reference
- 616 EUDAMEDFDA UDI
- Description
- Clinical Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816271020285 EUDAMEDFDA UDI
- Basic UDI-DI
- 081627102IMUDP EUDAMED
- Direct Marketing DI
- 00816271020285 EUDAMED
- FDA Product Code
- KQX FDA UDI
- EMDN Code
- Z12062502 KINEMATIC INERTIAL MOTION CAPTURE ANALYSIS SYSTEMS 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
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
Clinical 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 | 081627102IMUDP | 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 fece2738-73a0-4b27-8fb4-efa05a9b2829 61 fields · synced Jul 28, 2026
- FDA UDI e3b2f24b-ed64-4c34-a9d0-7cba28288900 35 fields · synced May 30, 2026