← Back to catalogue
PC-ECG Option I1
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HASP-SW-K-I1-01Model PC-ECG 1200 Software-Options
Identity
- Trade Name
- PC-ECG Option I1 EUDAMEDNorav 1200 Series PC-ECG FDA UDI
- Generic Name
- Cardiovascular risk evaluation interpretive software FDA UDI
- Device Name
- PC-ECG 1200 Series EUDAMEDNorav 1200 Series PC-ECG Software Kit with the following Option(s): - I1 = Resting-ECG Measurement Tool The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). FDA UDI
- Model / Reference
- PC-ECG 1200 Software-Options EUDAMEDHASP-SW-K-I1-01 EUDAMEDSW I1 FDA UDI
- Description
- Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I1 = Resting-ECG Measurement Tool The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick). FDA UDI
Identifiers
- Catalog Number
- HASP-SW-K-I1-01 FDA UDI
- Primary DI / UDI-DI
- 04260498562824 EUDAMED07290110252625 EUDAMEDFDA UDI
- Basic UDI-DI
- 426049856DE55252NMKEYVQ EUDAMED0729011720NM2069202KEYCW EUDAMED
- Direct Marketing DI
- 04260498562824 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z12050192 STRESS ANALYSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Cardiovascular risk evaluation interpretive software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
PC-ECG Option I1 by Norav Medical GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426049856DE55252NMKEYVQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Norav Medical GmbH
- EUDAMED SRN
- DE-MF-000006715
Sources (3)
- EUDAMED 61e218ca-c794-4016-a40c-0bb49c5caedd 61 fields · synced Oct 7, 2026
- FDA UDI 61d1aef2-0e73-4ae9-a5de-22bdae9ff38d 35 fields · synced May 30, 2026
- EUDAMED 9e38b858-b65c-4fc8-8a5f-1e09ae5208e6 61 fields · synced Oct 7, 2026