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Holter Analysis software. Includes download device according to recorder type.

FDA UDI

Class II (US FDA UDI)

by Norav Medical Inc.

Identity

Trade Name
Holter Analysis software. Includes download device according to recorder type. FDA UDI
Generic Name
Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Model / Reference
SOFT-NH300-2 FDA UDI

Identifiers

Primary DI / UDI-DI
07290110252700 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. Includes download device according to recorder type. 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 4a1aa81e-d923-4cb6-9baa-7ab9d6b50e3d 33 fields · synced Jun 8, 2026