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Sierra Wave
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 190266-200Model Neuro Accessory
Identity
- Trade Name
- Cadwell Sierra Wave EUDAMEDSierra Wave FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- Sierra Wave Stimtroller FDA UDIAmp-Stim Switch Box FDA UDI
- Model / Reference
- 190266-200 EUDAMEDFDA UDINeuro Accessory EUDAMED190217-200 FDA UDI
- Description
- Sierra Wave Stimtroller FDA UDIAmp-Stim Switch Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067100769 EUDAMEDFDA UDI00840067101209 FDA UDI
- Basic UDI-DI
- 08400671NeuroAccClass13E EUDAMED
- FDA Product Code
- GWJ FDA UDIGWF FDA UDIGWQ FDA UDIOLT FDA UDIGWE FDA UDIOLV FDA UDIIKN FDA UDIJXE FDA UDI
- EMDN Code
- Z12100480 ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1900 FDA UDI882.1870 FDA UDI882.1400 FDA UDI882.1890 FDA UDI890.1375 FDA UDI882.1550 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
Lot / Batch Number
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electromyograph
Sierra Wave by Cadwell Industries, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cadwell Industries, Inc.
Sources (3)
- FDA UDI 03c2d0ea-ca6f-4fb4-9704-7aec4ad817f1 34 fields · synced Sep 17, 2026
- FDA UDI 4a8e9e50-71bb-4e91-ae8f-53c4c4d5eb18 34 fields · synced May 30, 2026
- EUDAMED 5e0c6ea8-efdd-4afd-8dbd-36e5931b2926 61 fields · synced Jul 8, 2026