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Multi-parameter Patient Monitor
EUDAMEDClass IIb (EU MDR)
Ref K15ProModel K18ProRef K15 pro
Identity
- Trade Name
- Multi-parameter Patient Monitor EUDAMED
- Device Name
- Multi-parameter Patient Monitor EUDAMED
- Model / Reference
- K18Pro EUDAMEDK15Pro EUDAMEDK15 pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429020427 EUDAMED
- Basic UDI-DI
- 69454290PM007PN EUDAMEDB-06945429020427 EUDAMED
- Direct Marketing DI
- 06945429020427 EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Multi-parameter Patient 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 | 69454290PM007PN | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69454290PM007PN | 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 4d01ef6c-f9a0-47f3-89d4-e54a73e6d721 61 fields · synced Oct 6, 2026
- EUDAMED a8f359af-d6a3-4c2f-a413-90c1e92ecfac 61 fields · synced May 18, 2026