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Hd+

FDA UDI

Class II (US FDA UDI)

by Cardioline Spa

Identity

Trade Name
HD+ FDA UDI
Generic Name
Multichannel electrocardiograph, signal-averaging FDA UDI
Device Name
Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth, sends the data to the host. FDA UDI
Model / Reference
HD+ FDA UDI
Description
Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth, sends the data to the host. FDA UDI

Identifiers

Catalog Number
81018027 FDA UDI
Primary DI / UDI-DI
08056732654594 FDA UDI
510(k) Number
K150289 FDA UDI
FDA Product Code
DRG FDA UDI
GMDN Term
Multichannel electrocardiograph, signal-averaging FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2910 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: Multichannel electrocardiograph, signal-averaging

Hd+ by Cardioline Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multichannel electrocardiograph, signal-averaging.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardioline Spa

Sources (1)

  • FDA UDI 9227f10c-a953-47df-a8ce-2a0d261eeafb 37 fields · synced May 31, 2026