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IntelliVue XDS Software
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 867019Model IntelliVue XDS Software
Identity
- Trade Name
- IntelliVue XDS Software EUDAMEDFDA UDI
- Generic Name
- Bedside information system application software FDA UDI
- Device Name
- IntelliVue XDS Software EUDAMEDFDA UDI
- Model / Reference
- IntelliVue XDS Software EUDAMEDFDA UDI867019 EUDAMED
- Description
- IntelliVue XDS Software FDA UDI
Identifiers
- Catalog Number
- 867019 FDA UDI
- Primary DI / UDI-DI
- 00884838092099 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838092099 EUDAMED
- FDA Product Code
- MSX FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
- GMDN Term
- Bedside information system application software 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
Yes
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
MR Unsafe FDA UDI
IntelliVue XDS Software by Philips Medizin Systeme Böblingen GmbH — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K182637 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00884838092099 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (3)
- EUDAMED 8a107b7a-7592-4366-a303-30ae833f2b6e 61 fields · synced Jun 18, 2026
- FDA UDI a12ecb45-786c-4f0a-9190-07f58e22db69 35 fields · synced May 30, 2026
- FDA 510(k) K182637 1 fields · synced May 18, 2026