Identity
- Trade Name
- Ultium EMG Biofeedback App EUDAMED
- Device Name
- Wireless EMG Family Accessories EUDAMED
- Model / Reference
- APP01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816271020766 EUDAMED
- Basic UDI-DI
- 081627102EMGACCYN EUDAMED
- Direct Marketing DI
- 00816271020766 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
Ultium EMG Biofeedback App 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 | 081627102EMGACCYN | 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 85d9e7c4-40e7-44b4-92c7-98692954b291 61 fields · synced Jul 16, 2026