← Back to catalogue
LiDCO CNAP Assembly
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref HM 38-02 ASSEMBLY
by LiDCO Ltd
Identity
- Trade Name
- LiDCO CNAP Assembly EUDAMEDLiDCO Ltd FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- LiDCO CNAP Assembly EUDAMEDFDA UDI
- Model / Reference
- HM 38-02 ASSEMBLY EUDAMEDFDA UDI
- Description
- LiDCO CNAP Assembly FDA UDI
Identifiers
- Catalog Number
- HM 38-02 ASSEMBLY FDA UDI
- Primary DI / UDI-DI
- 05060110521258 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060110521258 EUDAMED
- 510(k) Number
- K131048 FDA UDI
- FDA Product Code
- DXG FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS 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
- Denmark 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
Yes
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
LiDCO CNAP Assembly by LiDCO Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060110521258 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LiDCO Ltd
- EUDAMED SRN
- GB-MF-000008036
- Authorised Representative
- LiDCO Netherlands B.V. NL-AR-000002681
Sources (2)
- EUDAMED 0e0c1d1a-1d94-4415-83a4-8ef9698e1f43 61 fields · synced Jun 18, 2026
- FDA UDI f63c4ee2-ccd9-471d-be09-e845d6f6b11b 36 fields · synced May 30, 2026