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LiDCO BP Module Assembly
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref HM 38-01 ASSEMBLYRef HM 38-01 AssemblyModel HM 38-01 LiDCO Blood Pressure Module Assembly
by LiDCO Ltd
Identity
- Trade Name
- LiDCO BP Module Assembly EUDAMEDHM 38-01 LiDCO Blood Pressure Module Assembly EUDAMEDLiDCO Ltd FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- LiDCO BP Module Assembly EUDAMEDFDA UDIHM 38-01 LiDCO Blood Pressure Module Assembly EUDAMED
- Model / Reference
- HM 38-01 ASSEMBLY EUDAMEDFDA UDIHM 38-01 LiDCO Blood Pressure Module Assembly EUDAMED
- Description
- LiDCO BP Module Assembly FDA UDI
Identifiers
- Catalog Number
- HM 38-01 ASSEMBLY FDA UDI
- Primary DI / UDI-DI
- 05060110520923 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060110520923 EUDAMED506011052000Y3T4C01V0007D EUDAMED
- Direct Marketing DI
- 05060110520923 EUDAMED
- 510(k) Number
- K122247 FDA UDI
- FDA Product Code
- DXG FDA UDI
- EMDN Code
- Z12039099 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS – OTHER EUDAMEDZ1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1435 FDA UDI
- Market of Registration
- Germany EUDAMEDNetherlands 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
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
No
EUDAMEDEUDAMED
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
LiDCO BP Module Assembly by LiDCO Ltd — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05060110520923 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-05060110520923 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- LiDCO Ltd
- EUDAMED SRN
- GB-MF-000008036
- Authorised Representative
- LiDCO Netherlands B.V. NL-AR-000002681
Sources (3)
- EUDAMED 67145d69-fc85-4014-9e0f-7406bbfe3ffd 61 fields · synced Jun 19, 2026
- FDA UDI af424217-5627-44eb-8b7b-d78e528514e7 36 fields · synced May 30, 2026
- EUDAMED 8a810af9-912b-438a-bec0-f3cc71031102 61 fields · synced Jun 19, 2026