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Servo-u Ventilator System

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 6694800

by Maquet Critical Care AB

Identity

Trade Name
Servo-u Ventilator System EUDAMED
BASE UNIT SERVO-U FDA UDI
Generic Name
Neonatal/adult intensive-care ventilator FDA UDI
Device Name
Servo -u / -n / -u MR EUDAMED
Model / Reference
6694800 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
07325710001110 EUDAMEDFDA UDI
Basic UDI-DI
7325710001117R EUDAMED
Direct Marketing DI
07325710001110 EUDAMED
510(k) Number
K151814 FDA UDI
K180098 FDA UDI
K201874 FDA UDI
FDA Product Code
CBK FDA UDI
EMDN Code
Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
GMDN Term
Neonatal/adult intensive-care ventilator FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
868.5895 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

Servo-u Ventilator System by Maquet Critical Care AB — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

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

Sources (2)

  • EUDAMED 5fc7a17b-0722-4ef8-964a-dfd50f58ecc2 61 fields · synced Jun 15, 2026
  • FDA UDI 4c09d224-0a5f-485a-8965-d068f7f370df 33 fields · synced May 30, 2026