Identity
- Trade Name
- myoRESEARCH (myoFORCE Software Module) EUDAMED
- Device Name
- Wireless IMU Family Accessories EUDAMED
- Model / Reference
- 406 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816271020803 EUDAMED
- Basic UDI-DI
- 081627102IMUACC5F EUDAMED
- Direct Marketing DI
- 00816271020803 EUDAMED
- EMDN Code
- Z12062482 BIOFEEDBACK INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
myoRESEARCH (myoFORCE Software Module) by Noraxon USA, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081627102IMUACC5F | Class I | Active |
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Manufacturer
- Manufacturer
- Noraxon USA, Inc.
- EUDAMED SRN
- US-MF-000003882
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED dd0d7ee5-6234-43eb-971e-a503e792ccfe 61 fields · synced Jul 17, 2026