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Flow-i C20

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 6888520

by Maquet Critical Care AB

Identity

Trade Name
Flow-i C20 EUDAMED
Flow-i C20 Anesthesia System FDA UDI
Generic Name
Anaesthesia workstation, general-purpose FDA UDI
Device Name
Flow Family EUDAMED
Model / Reference
6888520 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
07325710010617 EUDAMEDFDA UDI
Basic UDI-DI
73257100013485 EUDAMED
Direct Marketing DI
07325710010617 EUDAMED
510(k) Number
K191027 FDA UDI
FDA Product Code
BSZ FDA UDI
EMDN Code
Z1203010101 ANAESTHESIA DEVICES EUDAMED
GMDN Term
Anaesthesia workstation, general-purpose FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
868.5160 FDA UDI
Market of Registration
Sweden 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

Yes

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

Yes

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Flow-i C20 by Maquet Critical Care AB — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Maquet Critical Care AB
EUDAMED SRN
SE-MF-000001264

Sources (3)

  • EUDAMED e6473804-88a1-4939-b7bc-e92ccc63e5d7 61 fields · synced Oct 6, 2026
  • FDA UDI e736d278-cbbf-405b-9c24-4764aff3d050 33 fields · synced May 30, 2026
  • FDA 510(k) K112114 1 fields · synced Jun 9, 2026