Identity
- Trade Name
- Vital Signs Monitor EUDAMED
- Device Name
- Vital Signs Monitor EUDAMED
- Model / Reference
- NC5 EUDAMEDNC3B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429020724 EUDAMED
- Basic UDI-DI
- 69454290SM001QB EUDAMEDB-06945429020724 EUDAMED
- Direct Marketing DI
- 06945429020724 EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMEDZ12030299 VITAL SIGNS MONITORING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Iceland EUDAMEDBelgium 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
Vital Signs Monitor by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69454290SM001QB | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69454290SM001QB | 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 84de564b-a8c7-4ab6-aa4c-1ba9c70b9b1e 61 fields · synced Oct 8, 2026
- EUDAMED 7b79c9eb-d958-4d15-958e-b589dac5b827 61 fields · synced May 19, 2026