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LiDCOunity Hemodynamic Monitor
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref HM 92-01 MONITOR510(k) K152935
by LiDCO Ltd
Identity
- Trade Name
- LiDCOunity Hemodynamic Monitor EUDAMEDLiDCO Ltd FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- LiDCOunity Hemodynamic Monitor EUDAMEDLiDCOunity Hemodynamic Monitor, with Li-ion battery FDA UDI
- Model / Reference
- HM 92-01 MONITOR EUDAMEDFDA UDI
- Description
- LiDCOunity Hemodynamic Monitor, with Li-ion battery FDA UDI
Identifiers
- Catalog Number
- HM 92-01 MONITOR FDA UDI
- Primary DI / UDI-DI
- 05060110522026 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060110522026 EUDAMED
- 510(k) Number
- K163334 FDA UDI
- FDA Product Code
- DXG FDA UDI
- EMDN Code
- Z12039099 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS – OTHER EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1435 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
LiDCOunity Hemodynamic Monitor by LiDCO Ltd — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152935 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-05060110522026 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LiDCO Ltd
- EUDAMED SRN
- GB-MF-000008036
- FDA Applicant
- Lidco, Ltd.
- Authorised Representative
- LiDCO Netherlands B.V. NL-AR-000002681
Sources (3)
- EUDAMED 80bac7bc-a410-4480-8d19-50e2d940e282 85 fields · synced Jun 18, 2026
- FDA UDI f6a8a021-aec8-4b85-a948-56164e7da194 36 fields · synced May 30, 2026
- FDA 510(k) K152935 1 fields · synced May 18, 2026