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Patient Information Center iX
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 866389
Identity
- Trade Name
- Patient Information Center iX EUDAMEDFDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- Patient Information Center iX (PIC iX) EUDAMEDPatient Information Center iX FDA UDI
- Model / Reference
- 866389 EUDAMEDPatient Information Center iX FDA UDI
- Description
- Patient Information Center iX FDA UDI
Identifiers
- Catalog Number
- 866389 FDA UDI
- Primary DI / UDI-DI
- 00884838128880 EUDAMED00884838104594 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM855TT EUDAMED
- Direct Marketing DI
- 00884838128880 EUDAMED00884838104594 EUDAMED
- FDA Product Code
- MHX 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 UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not 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
Patient Information Center iX by Philips Medizin Systeme Böblingen GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211900 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM855TT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (4)
- EUDAMED 213d6e3f-63cd-4ced-b84f-68dc7d896e67 61 fields · synced Jul 11, 2026
- EUDAMED edd613d0-be26-4c50-9b28-a4a133db4abe 61 fields · synced May 17, 2026
- FDA UDI 2a33d037-73df-4957-9e50-17ea9b770e95 35 fields · synced May 30, 2026
- FDA 510(k) K211900 1 fields · synced May 18, 2026