EP navigator

FDA UDI

Class II (US FDA UDI)

by Philips Medical Systems Nederland B.V.

Identity

Trade Name: EP navigator FDA UDI
Generic Name: Angiographic x-ray system application software FDA UDI
Device Name: Software medical device, used with a Philips Interventional X-Ray System. Provides navigation support for cardiovascular devices for heart rhythm disorders. FDA UDI
Model / Reference: EP navigator - 5 FDA UDI
Description: Software medical device, used with a Philips Interventional X-Ray System. Provides navigation support for cardiovascular devices for heart rhythm disorders. FDA UDI

Identifiers

Catalog Number: 000071 FDA UDI
Primary DI / UDI-DI: 00884838059184 FDA UDI
510(k) Number: K142126 FDA UDI
FDA Product Code: OWB FDA UDI
LLZ FDA UDI
GMDN Term: Angiographic x-ray system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1650 FDA UDI
892.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Angiographic x-ray system application software

EP navigator by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
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 (1)

FDA UDI 856f78a1-1c7a-44ab-9ac6-fb98b9f35212 35 fields · synced Sep 18, 2026