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Cls L2.0

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 701049252

by Maquet Cardiopulmonary GmbH

Identity

Trade Name
CLS L2.0 EUDAMED
CARDIOHELP System FDA UDI
Generic Name
Cardiopulmonary bypass system air bubble/fluid level detector FDA UDI
Device Name
CLS L2.0 EUDAMED
The CLS is a device to monitor blood or saline level in a reservoir and to generate an electrical signal if the level falls below a predetermined value. FDA UDI
Model / Reference
701049252 EUDAMED
CLS L2.0 FDA UDI
Description
The CLS is a device to monitor blood or saline level in a reservoir and to generate an electrical signal if the level falls below a predetermined value. FDA UDI

Identifiers

Catalog Number
70104.9252 FDA UDI
Primary DI / UDI-DI
04037691682907 EUDAMEDFDA UDI
Basic UDI-DI
B-04037691682907 EUDAMED
510(k) Number
K102726 FDA UDI
FDA Product Code
DTQ FDA UDI
EMDN Code
Z12050280 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Cardiopulmonary bypass system air bubble/fluid level detector FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
870.4220 FDA UDI
Market of Registration
Germany 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

Yes

FDA UDI

Cls L2.0 by Maquet Cardiopulmonary GmbH — 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

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Manufacturer

Manufacturer
Maquet Cardiopulmonary GmbH
EUDAMED SRN
DE-MF-000020091

Sources (2)

  • EUDAMED d57110c6-ec40-4e2b-b97d-dbdbf2f6478d 61 fields · synced Jul 27, 2026
  • FDA UDI 8b0ad736-4c13-4095-92db-6c942e57180c 36 fields · synced May 30, 2026