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EEG CBL Lead Set Adult for 9 Elec.
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803180561
Identity
- Trade Name
- EEG CBL Lead Set Adult for 9 Elec. EUDAMEDEEG Cables and Lead Sets FDA UDI
- Generic Name
- Analytical scalp lead FDA UDI
- Device Name
- EEG Lead Sets EUDAMEDEEG Lead Set with 9 individual color coded leads for use on adults. Lead wires come with DIN connector on one end and hard mounted EEG silver cup electrodes on the other end. Individual leads are hold in place with a lead organizer. Silver cup diameter = 10mm, 80 cm (31.5 in) long leads.Use with trunk cable 989803180541 and conductive paste M1937A. FDA UDI
- Model / Reference
- 989803180561 EUDAMEDEEG CBL Lead Set Adult for 9 Elec. FDA UDI
- Description
- EEG Lead Set with 9 individual color coded leads for use on adults. Lead wires come with DIN connector on one end and hard mounted EEG silver cup electrodes on the other end. Individual leads are hold in place with a lead organizer. Silver cup diameter = 10mm, 80 cm (31.5 in) long leads.Use with trunk cable 989803180541 and conductive paste M1937A. FDA UDI
Identifiers
- Catalog Number
- 989803180561 FDA UDI
- Primary DI / UDI-DI
- 00884838037908 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM559TL EUDAMED
- FDA Product Code
- IKD 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
- 890.1175 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
Yes
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
EEG CBL Lead Set Adult for 9 Elec. 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 | 0884838BM559TL | 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 fe58fbf3-82c6-4636-9fad-c7204e497fcb 61 fields · synced Jun 20, 2026
- FDA UDI b5a3b099-dd12-4b93-bd85-93fe7f26e3d8 36 fields · synced May 30, 2026