Identity
- Trade Name
- Intellispace CC & Anesthesia EUDAMEDIntelliSpace Critical Care and Anesthesia FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- IntelliSpace CC & Anesthesia EUDAMEDIntelliSpace Critical Care and Anesthesia FDA UDI
- Model / Reference
- 866148 EUDAMEDIntelliSpace CC & Anesthesia J FDA UDI
- Description
- IntelliSpace Critical Care and Anesthesia FDA UDI
Identifiers
- Catalog Number
- 866148 FDA UDI
- Primary DI / UDI-DI
- 00884838113763 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM521ST EUDAMED
- Direct Marketing DI
- 00884838113763 EUDAMED
- FDA Product Code
- DJX FDA UDI
- EMDN Code
- Z11069001 BIOIMAGING PROCESSORS EUDAMED
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3380 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Bulgaria 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
Intellispace CC & Anesthesia 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 | 0884838BM521ST | 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 4f2fc625-fabf-422a-9102-3b7c57422dc0 61 fields · synced Jun 18, 2026
- FDA UDI ed7272c6-52dd-4059-b87c-6d35eaf885c2 35 fields · synced May 30, 2026