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Azurion 5 M20

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 722228

by Philips Medical Systems Nederland B.V.

Identity

Trade Name
Azurion 5 M20 EUDAMED
Azurion FDA UDI
Generic Name
Stationary angiographic x-ray system, digital FDA UDI
Device Name
Azurion series EUDAMED
Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inch flat detector. FDA UDI
Model / Reference
722228 EUDAMED
Azurion 5 M20 FDA UDI
Description
Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inch flat detector. FDA UDI

Identifiers

Catalog Number
722228 FDA UDI
Primary DI / UDI-DI
00884838099234 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM328SX EUDAMED
Direct Marketing DI
00884838099234 EUDAMED
510(k) Number
K200917 FDA UDI
FDA Product Code
OWB FDA UDI
JAA 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 EUDAMED
Class 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 5 M20 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

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Manufacturer

Manufacturer
Philips Medical Systems Nederland B.V.
EUDAMED SRN
NL-MF-000001489

Sources (2)

  • EUDAMED 5b614d8d-10a1-4df4-ac9c-860795fb366f 61 fields · synced Oct 5, 2026
  • FDA UDI 696a59b5-738c-4df6-96eb-046f48e9457c 35 fields · synced May 30, 2026