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EndoPATx

FDA UDI

Class II (US FDA UDI)

by Itamar Medical

Identity

Trade Name
EndoPATx FDA UDI
Generic Name
Cardiovascular-risk peripheral arterial tonometry system FDA UDI
Device Name
EndoPATx Device FDA UDI
Model / Reference
EndoPATx FDA UDI
Description
EndoPATx Device FDA UDI

Identifiers

Catalog Number
AS1650007 FDA UDI
Primary DI / UDI-DI
07290109225425 FDA UDI
510(k) Number
K211557 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiovascular-risk peripheral arterial tonometry system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Category: Cardiovascular-risk peripheral arterial tonometry system

EndoPATx by Itamar Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular-risk peripheral arterial tonometry system.

Cleared under the same submission

K211557 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Itamar Medical

Sources (1)

  • FDA UDI a16f96c3-fa38-4c73-ba25-2c248be5b54e 37 fields · synced May 30, 2026