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Holter analysis software + Data base. Includes download device according to reco

FDA UDI

Class II (US FDA UDI)

by Norav Medical Inc.

Identity

Trade Name
Holter analysis software + Data base. Includes download device according to reco FDA UDI
Generic Name
Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Model / Reference
SOFT-NH300-3 FDA UDI

Identifiers

Primary DI / UDI-DI
07290110252724 FDA UDI
FDA Product Code
MLO FDA UDI
GMDN Term
Electrocardiographic long-term ambulatory recording analyser application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2800 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 long-term ambulatory recording analyser application software

Holter analysis software + Data base. Includes download device according to reco by Norav Medical Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Electrocardiographic long-term ambulatory recording analyser application 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 4c9a36ee-cc81-4368-a9b9-c6eed63edc5b 33 fields · synced May 31, 2026