Identity
- Trade Name
- Core EMG Sensor EUDAMED
- Device Name
- Wireless EMG Family EUDAMED
- Model / Reference
- 816 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816271020735 EUDAMED
- Basic UDI-DI
- 081627102EMGC7 EUDAMED
- Direct Marketing DI
- 00816271020735 EUDAMED
- EMDN Code
- Z12100401 ELECTROMYOGRAPHS 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Core EMG Sensor 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 | 081627102EMGC7 | 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 fcbe516b-d973-4a79-890a-5849cf2066ed 61 fields · synced Jun 20, 2026