Identity
- Trade Name
- Vital Signs Monitor EUDAMED
- Device Name
- Vital Signs Monitor EUDAMED
- Model / Reference
- NC5A EUDAMEDNC5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429020748 EUDAMED
- Basic UDI-DI
- B-06945429020748 EUDAMED69454290SM001QB EUDAMED
- Direct Marketing DI
- 06945429020748 EUDAMED
- EMDN Code
- Z12030299 VITAL SIGNS MONITORING INSTRUMENTS - OTHER EUDAMEDZ1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMEDIceland 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
Category: Electrical-only medical device connection cable, reusable
Vital Signs Monitor by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06945429020748 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06945429020748 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 8dc355c6-8949-471d-a81a-c89254f39d64 61 fields · synced Jun 18, 2026
- EUDAMED 9f99bd2d-7172-45e8-940d-3b8cb0d4f2a4 61 fields · synced May 17, 2026