← Back to catalogue
Patient Cable CMO-N series
EUDAMEDClass I (EU MDR)
Ref CMO-05NTG-0.9URef CMO-03NTG-0.9URef CMO-04NTG-0.9U
Identity
- Trade Name
- Patient Cable CMO-N series EUDAMED
- Device Name
- Electrocardiographic lead set, reusable EUDAMED
- Model / Reference
- CMO-05NTG-0.9U EUDAMEDCMO-03NTG-0.9U EUDAMEDCMO-04NTG-0.9U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612061875 EUDAMED04538612061851 EUDAMED04538612061868 EUDAMED
- Basic UDI-DI
- 4538612030009U EUDAMED
- EMDN Code
- Z12039080 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Patient Cable CMO-N series by Fukuda Denshi Co., Ltd. — Class I — 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 | 4538612030009U | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fukuda Denshi Co., Ltd.
- EUDAMED SRN
- JP-MF-000008253
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED e92ac666-6df9-4878-875f-dc4c5057124d 61 fields · synced Jul 29, 2026
- EUDAMED f4daa3bf-44ff-41da-a8bd-e24232a9ef00 61 fields · synced May 17, 2026
- EUDAMED b17aaad5-79a9-4abe-9db7-2f3c87ce17b2 61 fields · synced May 17, 2026