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Geh-Ecg 1200wr
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1200WR-D-00-09Model PC-ECG 1200 Series
Identity
- Trade Name
- GEH-ECG 1200WR EUDAMEDNorav 1200 Series PC-ECG FDA UDI
- Generic Name
- Electrocardiographic signal amplifier FDA UDI
- Device Name
- PC-ECG 1200 EUDAMEDNorav Receiver for wireless PC-ECG Acquisition Device Norav 1200W with ECG Trigger Output. FDA UDI
- Model / Reference
- PC-ECG 1200 Series EUDAMED1200WR-D-00-09 EUDAMED1200WR FDA UDI
- Description
- Norav Receiver for wireless PC-ECG Acquisition Device Norav 1200W with ECG Trigger Output. FDA UDI
Identifiers
- Catalog Number
- 1200WR-D-00-09 FDA UDI
- Primary DI / UDI-DI
- 04260498566907 EUDAMEDFDA UDI
- Basic UDI-DI
- 426049856DE55252NMDECT9 EUDAMED
- Direct Marketing DI
- 04260498566907 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z12050101 STRESS ANALYSIS SYSTEMS EUDAMED
- GMDN Term
- Electrocardiographic signal amplifier FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Geh-Ecg 1200wr 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 | 426049856DE55252NMDECT9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Norav Medical GmbH
- EUDAMED SRN
- DE-MF-000006715
Sources (2)
- EUDAMED 6edb3898-2735-4407-9077-8d16777f32b2 61 fields · synced Oct 6, 2026
- FDA UDI 175f23bf-5a5a-4823-83e6-6f715b5f99b6 35 fields · synced May 26, 2026