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Easy Ambulatory
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 197208-200Model Neuro Accessory
Identity
- Trade Name
- Easynet Ambulatory EUDAMEDEasy Ambulatory FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Easynet Ambulatory Microphone FDA UDI
- Model / Reference
- 197208-200 EUDAMEDFDA UDINeuro Accessory EUDAMED
- Description
- Easynet Ambulatory Microphone FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067100660 EUDAMEDFDA UDI
- Basic UDI-DI
- 08400671NeuroAccClass13E EUDAMED
- 510(k) Number
- K946094 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- EMDN Code
- N010180 NEUROPHYSIOLOGY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 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 UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electroencephalograph
Easy Ambulatory by Cadwell Industries, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalograph.
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- Natus — Natus Neurology Incorporated · Class II
- 128-channel EEG cap (L) — Megin Oy · Class II
- Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
- Zeto ONE Head Unit - Small — ZETO INC · Class II
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 (2)
- FDA UDI f6ff7bcf-d85f-438b-bde2-e522d7607950 35 fields · synced Jul 9, 2026
- EUDAMED 53a414ab-d050-42bb-b16c-cbe4ed1a76be 61 fields · synced Jul 9, 2026