Identity
- Trade Name
- K Myo EUDAMEDFDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- K Myo EUDAMEDK Myo is a biofeedback device for training muscle groups by means of electromyography FDA UDI
- Model / Reference
- MP.10.02.FN EUDAMEDK Myo V3 FDA UDI
- Description
- K Myo is a biofeedback device for training muscle groups by means of electromyography FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770011995707 EUDAMEDFDA UDI
- Basic UDI-DI
- 3770011995KMyo95 EUDAMED
- Direct Marketing DI
- 03770011995707 EUDAMED
- FDA Product Code
- HCC FDA UDI
- EMDN Code
- Z12062401 ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS EUDAMED
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
K Myo by Kinvent Biomecanique — 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 | 3770011995KMyo95 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- KINVENT Biomecanique
- EUDAMED SRN
- FR-MF-000031884
Sources (2)
- EUDAMED ea8dc3e9-8e70-4cb5-b7d6-c13f6cd945b2 61 fields · synced Jun 18, 2026
- FDA UDI 5d9b7107-0556-4cc6-9801-a07f1c557181 35 fields · synced May 30, 2026