Identity
- Trade Name
- Azurion 7 B12 EUDAMEDAzurion FDA UDI
- Generic Name
- Stationary angiographic x-ray system, digital FDA UDI
- Device Name
- Azurion series EUDAMEDBiplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ceiling-mounted lateral stand (12-inch flat detector) and optional interface for an OR table. FDA UDI
- Model / Reference
- 722235 EUDAMEDAzurion 7 B12 FDA UDI
- Description
- Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ceiling-mounted lateral stand (12-inch flat detector) and optional interface for an OR table. FDA UDI
Identifiers
- Catalog Number
- 722235 FDA UDI
- Primary DI / UDI-DI
- 00884838116788 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM328SX EUDAMED
- Direct Marketing DI
- 00884838116788 EUDAMED
- 510(k) Number
- K200917 FDA UDI
- FDA Product Code
- OWB FDA UDIJAA FDA UDI
- EMDN Code
- Z11030102 STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES EUDAMED
- GMDN Term
- Stationary angiographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Azurion 7 B12 by Philips Medical Systems Nederland B.V. — 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 | 0884838BM328SX | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED 42dfd368-d6f3-4442-abff-9d4d3539758b 61 fields · synced Oct 6, 2026
- FDA UDI 1691cf44-6e00-4c8f-9e3f-d2ef7bee1874 36 fields · synced May 29, 2026