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PC-ECG Option I3
EUDAMEDClass IIa (EU MDR)
Ref HASP-SW-K-I3-01Model PC-ECG 1200 Software-Options
Identity
- Trade Name
- PC-ECG Option I3 EUDAMED
- Device Name
- PC-ECG 1200 Series EUDAMED
- Model / Reference
- PC-ECG 1200 Software-Options EUDAMEDHASP-SW-K-I3-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260498562855 EUDAMED
- Basic UDI-DI
- 426049856DE55252NMKEYVQ EUDAMED
- Direct Marketing DI
- 04260498562855 EUDAMED
- EMDN Code
- Z12050192 STRESS ANALYSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PC-ECG Option I3 by Norav Medical GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426049856DE55252NMKEYVQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Norav Medical GmbH
- EUDAMED SRN
- DE-MF-000006715
Sources (1)
- EUDAMED b2c66277-8e15-40ba-b6a6-b9920eb2b521 61 fields · synced Jun 19, 2026