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Nr-1207-3
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref NR12073-D-00E-04Model NR Series ECG-Recorders
Identity
- Trade Name
- NR-1207-3 EUDAMED
- Device Name
- NR Series EUDAMED
- Model / Reference
- NR Series ECG-Recorders EUDAMEDNR12073-D-00E-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260498565405 EUDAMED
- Basic UDI-DI
- 426049856DE55252NMNRSX2 EUDAMED
- Direct Marketing DI
- 04260498565405 EUDAMED
- EMDN Code
- Z12050101 STRESS ANALYSIS SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nr-1207-3 by Norav Medical GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161062 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 426049856DE55252NMNRSX2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Norav Medical GmbH
- EUDAMED SRN
- DE-MF-000006715
Sources (2)
- EUDAMED bead71b4-1c04-4ff2-a649-bfc4e860e23e 61 fields · synced Jun 19, 2026
- FDA 510(k) K161062 1 fields · synced May 18, 2026