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Solid Gel Dual Electrodes (QTY: 210)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 271SCASE
Identity
- Trade Name
- Solid Gel Dual Electrodes (QTY: 210) EUDAMEDDual EMG Electrodes FDA UDI
- Generic Name
- Kinesiology/electromyographic sensor set FDA UDI
- Device Name
- Wireless EMG Family Accessories EUDAMEDSolid Gel Ag/AgCl Dual EMG Electrodes 210 pieces per case FDA UDI
- Model / Reference
- 271SCASE EUDAMEDFDA UDI
- Description
- Solid Gel Ag/AgCl Dual EMG Electrodes 210 pieces per case FDA UDI
Identifiers
- Catalog Number
- 271SCASE FDA UDI
- Primary DI / UDI-DI
- 10816271020084 EUDAMEDFDA UDI
- Basic UDI-DI
- 081627102EMGACCYN EUDAMED
- FDA Product Code
- HCC FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Kinesiology/electromyographic sensor set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Solid Gel Dual Electrodes (QTY: 210) 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 | 081627102EMGACCYN | 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 993f17ff-13c0-435b-bfaf-9e925b6e84aa 61 fields · synced Jul 20, 2026
- FDA UDI 3d191b62-2dd7-438a-9dd4-ceb332030626 34 fields · synced May 30, 2026