IntelliVue EEG Module
by Philips Medizin Systeme Böblingen GmbH
Ref 866078
Active
CE MDD
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/MDD EUDAMED | NumberB-00884838031999 00884838031999 | Date16 May 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00884838031999 | Date6 Oct 2016 | 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- Withdrawn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
- IntelliVue EEG Module EUDAMEDEEG Module GUDID
- Generic Name
- Patient monitoring system module, electroencephalographic
- Model / Ref / Catalog
- 866078, IntelliVue EEG Module
- Primary DI / UDI-DI
- 00884838031999
- Basic UDI-DI
- B-00884838031999
- FDA Product Code
- DSJ
- EMDN Code
- Z12030280 Vital signs monitoring instruments - hardware accessories
- GMDN Term
- Patient monitoring system module, electroencephalographic
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 870.1100
- EU market of registration
- Austria
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 866078 | IntelliVue EEG Module |
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000006026
Other devices from Philips Medizin Systeme Böblingen GmbH
See all devices from Philips Medizin Systeme Böblingen GmbH →
Properties
Other properties (21)
- 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
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No