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12 lead ECG for rest.

FDA UDI

Class II (US FDA UDI)

by Norav Medical Inc.

Identity

Trade Name
12 lead ECG for rest. FDA UDI
Generic Name
Electrocardiographic signal amplifier FDA UDI
Device Name
PC-ECG Acquisition Device for Resting-ECG recordings with AHA type labelling. FDA UDI
Model / Reference
PCECG 1200M FDA UDI
Description
PC-ECG Acquisition Device for Resting-ECG recordings with AHA type labelling. FDA UDI

Identifiers

Catalog Number
1200M-D-00U-01 FDA UDI
Primary DI / UDI-DI
07290110252854 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

Yes

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: Electrocardiographic signal amplifier

12 lead ECG for rest. 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

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Manufacturer

Manufacturer
Norav Medical Inc.

Sources (1)

  • FDA UDI 5699bf8c-e52c-4035-b530-e369e46618c4 35 fields · synced Jun 1, 2026