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Holter Monitor

FDA UDI

Class II (US FDA UDI)

by Memtec Corporation

Identity

Trade Name
Holter Monitor FDA UDI
Generic Name
Electrocardiographic long-term ambulatory recording analyser FDA UDI
Device Name
Holter Monitor FDA UDI
Model / Reference
Model 950-3CH FDA UDI
Description
Holter Monitor FDA UDI

Identifiers

Catalog Number
1 FDA UDI
Primary DI / UDI-DI
00860002827308 FDA UDI
FDA Product Code
DSH 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic long-term ambulatory recording analyser

Holter Monitor by Memtec 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
Memtec Corporation

Sources (1)

  • FDA UDI cb54d5d0-a772-4a13-9e03-411a7b0cb6ff 35 fields · synced May 30, 2026