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Holter ECG and ABP System

FDA UDI

Class II (US FDA UDI)

by Edan Instruments, Inc.

Identity

Trade Name
Holter ECG and ABP System FDA UDI
Generic Name
Electrocardiographic ambulatory recorder FDA UDI
Model / Reference
SA-19 FDA UDI

Identifiers

Primary DI / UDI-DI
06944413820494 FDA UDI
510(k) Number
K230184 FDA UDI
FDA Product Code
DSH FDA UDI
DXN FDA UDI
GMDN Term
Electrocardiographic ambulatory recorder FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2800 FDA UDI
870.1130 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
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic ambulatory recorderBlood pressure ambulatory recorder

Holter ECG and ABP System by Edan Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood pressure ambulatory recorder.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edan Instruments, Inc.

Sources (1)

  • FDA UDI 49f817a0-5957-4eec-99cb-85c4de4ab71d 33 fields · synced May 30, 2026