Identity
- Trade Name
- Norav 1200 Series PC-ECG FDA UDI
- Generic Name
- Electrocardiographic signal amplifier FDA UDI
- Device Name
- Kit includes: PC-ECG 1200HR (UDI: 07290110255275) for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG Trigger Output and IEC type labelling. Input cable with 10 Patient leads IEC type and Snap connectors. Special edition LO Kit for COSMED FDA UDI
- Model / Reference
- 1200HRT Kit FDA UDI
- Description
- Kit includes: PC-ECG 1200HR (UDI: 07290110255275) for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG Trigger Output and IEC type labelling. Input cable with 10 Patient leads IEC type and Snap connectors. Special edition LO Kit for COSMED FDA UDI
Identifiers
- Catalog Number
- 1200HRT-K-01-E-S10-03 FDA UDI
- Primary DI / UDI-DI
- 07290110255282 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
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
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- 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 833a3a7f-8ad0-45c1-a1b4-f1f3c40729e4 35 fields · synced May 30, 2026