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Norav 1200 Series PC-ECG

FDA UDI

Class II (US FDA UDI)

by Norav Medical Inc.

Identity

Trade Name
Norav 1200 Series PC-ECG FDA UDI
Generic Name
Patient-administration information system application software FDA UDI
Device Name
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). FDA UDI
Model / Reference
SW S2-I2 FDA UDI
Description
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). FDA UDI

Identifiers

Catalog Number
HASP-SW-K-S2I2-01 FDA UDI
Primary DI / UDI-DI
07290110255022 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
Patient-administration information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiopulmonary stress exercise monitoring system computerPatient-administration information system application softwareCardiovascular risk evaluation interpretive software

Norav 1200 Series PC-ECG by Norav Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular risk evaluation interpretive software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Norav Medical Inc.

Sources (1)

  • FDA UDI ed5b2b4b-042c-4331-b2a2-7656156cd4cb 35 fields · synced Jun 8, 2026