← Back to catalogue

CardioCare2000

FDA UDI

Class II (US FDA UDI)

by Bionet Company, Ltd.

Identity

Trade Name
CardioCare2000 FDA UDI
Generic Name
ST-segment electrocardiographic monitor FDA UDI
Device Name
System, ecg analysis FDA UDI
Model / Reference
CardioCare2000 FDA UDI
Description
System, ecg analysis FDA UDI

Identifiers

Primary DI / UDI-DI
08809276943538 FDA UDI
510(k) Number
K011328 FDA UDI
FDA Product Code
DPS FDA UDI
GMDN Term
ST-segment electrocardiographic monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2340 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

No

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: ST-segment electrocardiographic monitor

CardioCare2000 by Bionet Company, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ST-segment electrocardiographic monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bionet Company, Ltd.

Sources (1)

  • FDA UDI 27b1d62a-d79d-45b7-aa4d-699851e98c77 34 fields · synced May 31, 2026