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Midmark IQholter Digital Holter

FDA UDI

Class II (US FDA UDI)

by Midmark Corporation

Identity

Trade Name
Midmark IQholter Digital Holter FDA UDI
Generic Name
Electrocardiographic long-term ambulatory recording analyser FDA UDI
Device Name
The Midmark IQholter system combines a compact digital recorder with three powerful software applications. Easy-to-use Holter software with fully automated analysis and reporting, designed for routine monitoring situations in fast-paced offices. Kit includes: Midmark IQholter Recorder (includes lead wire set, secure digital card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key USB Version, and Holter Prep Kits. FDA UDI
Model / Reference
4-000-0110 FDA UDI
Description
The Midmark IQholter system combines a compact digital recorder with three powerful software applications. Easy-to-use Holter software with fully automated analysis and reporting, designed for routine monitoring situations in fast-paced offices. Kit includes: Midmark IQholter Recorder (includes lead wire set, secure digital card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key USB Version, and Holter Prep Kits. FDA UDI

Identifiers

Catalog Number
4-000-0110 FDA UDI
Primary DI / UDI-DI
00841709100598 FDA UDI
FDA Product Code
MLO FDA UDI
GMDN Term
Electrocardiographic long-term ambulatory recording analyser FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2800 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: Electrocardiographic long-term ambulatory recording analyser

Midmark IQholter Digital Holter by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic long-term ambulatory recording analyser.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Midmark Corporation

Sources (1)

  • FDA UDI 98123a1f-0466-498f-8beb-93024466d3d2 37 fields · synced Jun 8, 2026