Dc-Eeg 3 Disc Electrode Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- DC-EEG Three Disc Cable Electrode Kit; DC-EEG Monopolar / Bipolar Electrode Kit; DC-EEG Linked Ear Attachment Kit; DC-EEG Two Channel Connectivity Kit EUDAMEDDC-EEG 3 DISC ELECTRODE KIT FDA UDI
- Generic Name
- Psychophysiological biofeedback system FDA UDI
- Device Name
- DC-EEG Electrode Kits EUDAMED
- Model / Reference
- DC-EEG Electrode Kits EUDAMEDT8770; T8775; T8780; T8785 EUDAMEDT8770 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540191000357 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540191000639F EUDAMED
- 510(k) Number
- K903497 FDA UDI
- FDA Product Code
- HCC FDA UDI
- EMDN Code
- N01010202 EEG EXTRACRANIC ELECTRODES EUDAMED
- GMDN Term
- Psychophysiological biofeedback system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Psychophysiological biofeedback system
Dc-Eeg 3 Disc Electrode Kit by Thought Technology Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K903497 also covers:
- 100 Triodes Self Adhesive — Thought Technology Ltd.
- Bend Sensor Assembly — Thought Technology Ltd.
- DC-EEG LINKED EAR ATTACHMENT KIT — Thought Technology Ltd.
- DC-EEG MONO/BIPOLAR ELECTRODE KIT — Thought Technology Ltd.
- DC-EEG TWO CHANNEL CONNECTIVIT KIT — Thought Technology Ltd.
- EEG-Z3 — Thought Technology Ltd.
- EKG Receiver for Polar — Thought Technology Ltd.
- Electrodes 100 Unigel Single — Thought Technology Ltd.
- Flexcomp Infiniti Encoder — Thought Technology Ltd.
- Forcetrac — Thought Technology Ltd.
- Inclinotrac Sensor — Thought Technology Ltd.
- Procomp 2 Encoder Device — Thought Technology Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Thought Technology Ltd.
Sources (3)
- FDA UDI b9b61165-efcb-4c29-b0fb-fd6765721cb1 33 fields · synced Jul 9, 2026
- EUDAMED cbd57582-84f7-4e84-a6f3-fd7ce910b860-1 61 fields · synced Jul 9, 2026
- EUDAMED cbd57582-84f7-4e84-a6f3-fd7ce910b860-2 61 fields · synced Jul 9, 2026