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Reusable EEG Adult Cup Electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803105621
Identity
- Trade Name
- Reusable EEG Adult Cup Electrodes EUDAMEDEEG Electrodes FDA UDI
- Generic Name
- Analytical scalp lead FDA UDI
- Device Name
- EEG Electrodes EUDAMEDEEG Lead Set Adult 5 Elec. FDA UDI
- Model / Reference
- 989803105621 EUDAMEDReusable EEG Adult Cup Electrodes FDA UDI
- Description
- EEG Lead Set Adult 5 Elec. FDA UDI
Identifiers
- Catalog Number
- 989803105621 FDA UDI
- Primary DI / UDI-DI
- 00884838011861 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM558TJ EUDAMED
- FDA Product Code
- GWQ FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Analytical scalp lead FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Market of Registration
- Austria 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Reusable EEG Adult Cup Electrodes by Philips Medizin Systeme Böblingen GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0884838BM558TJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED 47bab706-a7b7-491e-bd90-4f7bd2cdd6ae 61 fields · synced Jun 18, 2026
- FDA UDI e5209821-5c4d-404b-869f-42ed0f043b6c 36 fields · synced May 30, 2026