CBL Reusable EEG Pedi Cup Electrodes
by Philips Medizin Systeme Böblingen GmbH
Ref 989803105631
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0884838BM558TJ 00884838011878 | Date1 Oct 2024 | StatusActive |
| United States | GUDID listing GUDID | Number00884838011878 | Date18 Apr 2017 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- CBL Reusable EEG Pedi Cup Electrodes EUDAMEDEEG Electrodes GUDID
- Generic Name
- Analytical scalp lead
- Model / Ref / Catalog
- 989803105631, CBL Reusable EEG Pedi Cup Electrodes
- Primary DI / UDI-DI
- 00884838011878
- Basic UDI-DI
- 0884838BM558TJ
- FDA Product Code
- GWQ
- EMDN Code
- Z1203020280 Multi-parameter monitors - hardware accessories
- GMDN Term
- Analytical scalp lead
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 882.1400
- EU market of registration
- Austria
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 989803105631 | CBL Reusable EEG Pedi Cup Electrodes |
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000006026
Other devices from Philips Medizin Systeme Böblingen GmbH
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Properties
Other properties (22)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No