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Flow Regulator Assembly
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CM 33
by LiDCO Ltd
Identity
- Trade Name
- Flow Regulator Assembly EUDAMEDFlow Regulator EUDAMEDLiDCO Ltd FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Flow Regulator Assembly EUDAMEDFDA UDIFlow Regulator EUDAMED
- Model / Reference
- CM 33 EUDAMEDFDA UDI
- Description
- Flow Regulator Assembly FDA UDI
Identifiers
- Catalog Number
- CM 33 FDA UDI
- Primary DI / UDI-DI
- 05060110520800 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060110520800 EUDAMED506011052000Z7T5C01V005CV EUDAMED
- Direct Marketing DI
- 05060110520800 EUDAMED
- 510(k) Number
- K023960 FDA UDI
- FDA Product Code
- DXG FDA UDI
- EMDN Code
- Z12050580 CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1435 FDA UDI
- Market of Registration
- Greece 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
Yes
EUDAMEDEUDAMED
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
Flow Regulator Assembly by LiDCO Ltd — Class IIa — 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-05060110520800 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05060110520800 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 b3506ed8-d549-4360-b70e-d829f011aeb1 61 fields · synced Aug 4, 2026
- FDA UDI 08ebb828-ed04-4c50-b08c-229132af65c3 36 fields · synced May 30, 2026
- EUDAMED 9e187eb7-6c3b-4f4a-8eec-6ce59d5b8ec6 61 fields · synced Aug 4, 2026