Identity
- Trade Name
- CareEvent EUDAMEDFDA UDI
- Generic Name
- Hospital-administration information system FDA UDI
- Device Name
- CareEvent EUDAMEDCareEvent is a distributed alarming solution. With CareEvent the Philips Alarm distribution solution includes rules and escalation levels to deliver the right alarm to the right caregiver with the right information on a mobile device. FDA UDI
- Model / Reference
- CareEvent EUDAMEDFDA UDI866435 EUDAMED
- Description
- CareEvent is a distributed alarming solution. With CareEvent the Philips Alarm distribution solution includes rules and escalation levels to deliver the right alarm to the right caregiver with the right information on a mobile device. FDA UDI
Identifiers
- Catalog Number
- 866435 FDA UDI
- Primary DI / UDI-DI
- 00884838099128 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838099128 EUDAMED
- FDA Product Code
- MSX FDA UDI
- EMDN Code
- Z12039082 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Hospital-administration information system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Special Device Type
- -1192 EUDAMED
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
CareEvent by Philips Medical Systems — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142935 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00884838099128 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED f3aba5ff-85f7-4813-b007-edd4954c998b 61 fields · synced Sep 18, 2026
- FDA UDI 6b1bb35e-7cf5-459f-863b-7ea6beb742bb 35 fields · synced May 30, 2026
- FDA 510(k) K142935 1 fields · synced May 18, 2026