Identity
- Trade Name
- Norav 1200 Series PC-ECG FDA UDI
- Generic Name
- Cardiovascular risk evaluation interpretive software FDA UDI
- Device Name
- Norav 1200 Series PC-ECG Software Kit with the following Option(s): - H1 = Heart Rate Variability Analysis The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). FDA UDI
- Model / Reference
- SW H1 FDA UDI
- Description
- Norav 1200 Series PC-ECG Software Kit with the following Option(s): - H1 = Heart Rate Variability Analysis The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). FDA UDI
Identifiers
- Catalog Number
- HASP-SW-K-H1-01 FDA UDI
- Primary DI / UDI-DI
- 07290110252618 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Cardiovascular risk evaluation interpretive 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: Cardiovascular 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.
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- Norav 1200 Series PC-ECG — Norav Medical Inc. · Class II
- Norav 1200 Series PC-ECG — Norav Medical Inc. · Class II
- Norav 1200 Series PC-ECG — Norav Medical Inc. · Class II
- Norav 1200 Series PC-ECG — Norav Medical Inc. · Class II
- Norav 1200 Series PC-ECG — Norav Medical Inc. · Class II
- Norav 1200 Series PC-ECG — Norav Medical Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Norav Medical Inc.
Sources (1)
- FDA UDI be91de14-2db8-45f5-8d02-fa0abc460319 35 fields · synced May 30, 2026