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LiDCO Ltd

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref HM 38-02 Assembly

by Lidco Limited

Identity

Trade Name
LiDCO CNAP Assembly EUDAMED
LiDCO Ltd FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
LiDCO CNAP Assembly EUDAMED
LiDCO CNAP Module FDA UDI
Model / Reference
HM 38-02 Assembly EUDAMED
HM 38-02 MODULE FDA UDI
Description
LiDCO CNAP Module FDA UDI

Identifiers

Catalog Number
HM 38-02 MODULE FDA UDI
Primary DI / UDI-DI
05060110521241 EUDAMEDFDA UDI
Basic UDI-DI
506011052000Z7T4C01V000BY EUDAMED
Direct Marketing DI
05060110521241 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 IIa EUDAMED
Class II FDA UDI
Regulation Number
870.1435 FDA UDI
Market of Registration
Netherlands 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

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

Category: General-purpose multi-parameter bedside monitor

LiDCO Ltd by Lidco Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose multi-parameter bedside monitor.

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lidco Limited

Sources (2)

  • FDA UDI 2e0a334a-f56a-40c5-9764-a10d500d77aa 36 fields · synced Jun 19, 2026
  • EUDAMED a4e3abb9-81e9-4dd8-826e-759194ee72fd 61 fields · synced Jun 19, 2026