Identity
- Trade Name
- Care Assist Android EUDAMEDCare Assist FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- Care Assist App EUDAMEDCare Assist FDA UDI
- Model / Reference
- 989803221541 EUDAMEDCare Assist Android 4.2 FDA UDI
- Description
- Care Assist FDA UDI
Identifiers
- Catalog Number
- 989803221541 FDA UDI
- Primary DI / UDI-DI
- 00884838123724 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1761MY EUDAMED
- Direct Marketing DI
- 00884838123724 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 Android 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 93ed0c20-76ee-407b-8914-e40fd1c36c6d 61 fields · synced Jun 18, 2026
- FDA UDI 89d7597b-3332-47bb-82c9-af4d24972b22 34 fields · synced May 30, 2026