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Multi-parameter Patient Monitor
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref Datalys 780Ref MR-M60Model MR-M80TRef N10Ref MR-M60ERef ND12CModel ND15S 510(k) K191106Ref ND10Ref K12AModel K12Ref OPUS i10 Expert
Identity
- Trade Name
- Multi-parameter Patient Monitor EUDAMED
- Device Name
- Multi-parameter Patient Monitor EUDAMEDMulti-paramater patient monitor EUDAMED
- Model / Reference
- Datalys 780 EUDAMEDMR-M80T EUDAMEDMR-M60 EUDAMEDN10 EUDAMEDMR-M60E EUDAMEDND15S EUDAMEDND12C EUDAMEDND10 EUDAMEDK12 EUDAMEDK12A EUDAMEDOPUS i10 Expert EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429020144 EUDAMED06945429027495 EUDAMED06945429023046 EUDAMED06945429027501 EUDAMED06945429028942 EUDAMED06945429028881 EUDAMED06945429061666 EUDAMED06945429020366 EUDAMED
- Basic UDI-DI
- B-06945429020144 EUDAMED69454290MR001PC EUDAMED69454290PM011PD EUDAMED69454290PM013PH EUDAMED69454290PM016PP EUDAMEDB-06945429020366 EUDAMED
- Direct Marketing DI
- 06945429027495 EUDAMED06945429027501 EUDAMED06945429028942 EUDAMED06945429028881 EUDAMED
- 510(k) Number
- K191106 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Market of Registration
- Belgium EUDAMEDIceland EUDAMEDIreland EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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 — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191106 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06945429020144 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | B-06945429020144 | 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 (9)
- EUDAMED ce501b76-2473-4e1e-a7b8-eb4a94d5bf1d 61 fields · synced Oct 6, 2026
- EUDAMED 84d28525-b77b-4939-ba8f-d9b65c1c4eda 61 fields · synced May 16, 2026
- EUDAMED d7d944af-ccde-4f88-9bf4-143d33885aeb 61 fields · synced May 17, 2026
- EUDAMED e6a85e07-3e72-48b1-bc09-8395eb18f3ba 61 fields · synced May 17, 2026
- EUDAMED bd2a7774-bdf0-4959-bb30-69227a455e24 61 fields · synced May 17, 2026
- FDA 510(k) K191106 24 fields · synced May 18, 2026
- EUDAMED 508e1580-8f26-48bc-b6e1-9caa468ba256 61 fields · synced Jul 11, 2026
- EUDAMED 631079cd-b989-412e-8157-0a602cba98bf 61 fields · synced Jul 19, 2026
- EUDAMED d1199d69-732f-476a-8475-c3d9ea799fcf 61 fields · synced Jul 27, 2026