← Back to catalogue

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
Electrocardiographic signal amplifier FDA UDI
Device Name
PC-ECG Acquisition Device for Stress-Test ECG recordings with IEC type labelling BMS. FDA UDI
Model / Reference
1200S FDA UDI
Description
PC-ECG Acquisition Device for Stress-Test ECG recordings with IEC type labelling BMS. FDA UDI

Identifiers

Catalog Number
1200S-D-03E-01 FDA UDI
Primary DI / UDI-DI
07290110254100 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
Electrocardiographic signal amplifier 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

No

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: Electrocardiographic signal amplifier

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 Electrocardiographic signal amplifier.

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
Norav Medical Inc.

Sources (1)

  • FDA UDI ae16554b-5ebe-40b3-8687-5b3fb6b705c8 35 fields · synced May 30, 2026