Identity
- Trade Name
- Care Assist iOS EUDAMEDCare Assist FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- Care Assist App EUDAMEDCare Assist FDA UDI
- Model / Reference
- 989803221531 EUDAMEDCare Assist iOS 4.2 FDA UDI
- Description
- Care Assist FDA UDI
Identifiers
- Catalog Number
- 989803221531 FDA UDI
- Primary DI / UDI-DI
- 00884838123717 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1761MY EUDAMED
- Direct Marketing DI
- 00884838123717 EUDAMED
- FDA Product Code
- MHX FDA UDIDSH FDA UDIDSI FDA UDIMLD FDA UDIMSX FDA UDIOUG FDA UDI
- EMDN Code
- Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED
- GMDN Term
- Centralized patient monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI870.2800 FDA UDI870.2300 FDA UDI880.6310 FDA UDI
- Special Device Type
- Software 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
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
Care Assist iOS by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0884838BM1761MY | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED 6477ae13-8706-4e57-81ee-66965569c2a8 61 fields · synced Jun 19, 2026
- FDA UDI 5c8ebf16-d86e-41f8-b41e-ebdc08313837 34 fields · synced May 30, 2026