Identity
- Trade Name
- Philips Hemodynamic Application EUDAMEDFDA UDI
- Generic Name
- Haemodynamic monitoring system application software FDA UDI
- Device Name
- Philips Hemodynamic Application EUDAMEDSoftware medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment. FDA UDI
- Model / Reference
- 002010 EUDAMEDPhilips Hemodynamic Application - 1 FDA UDI
- Description
- Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment. FDA UDI
Identifiers
- Catalog Number
- 002010 FDA UDI
- Primary DI / UDI-DI
- 00884838084544 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM701SX EUDAMED
- Direct Marketing DI
- 00884838084544 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z12050782 INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Haemodynamic monitoring system application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
Category: Haemodynamic monitoring system application software
Philips Hemodynamic Application by Philips Medical Systems Nederland B.V. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
Sources (2)
- FDA UDI bf0e6c6e-94de-4f87-93c5-b3ad99964c9e 34 fields · synced Oct 6, 2026
- EUDAMED 9366066a-61d9-48cd-b8fe-524f022a2661 61 fields · synced Jul 28, 2026