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Voluson SWIFT+

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref H43222LRModel Voluson SWIFT

by GE Ultrasound Korea, Ltd.

Identity

Trade Name
Voluson SWIFT+ EUDAMED
Voluson FDA UDI
Generic Name
General-purpose ultrasound imaging system FDA UDI
Device Name
Voluson SWIFT Voluson SWIFT + EUDAMED
Voluson SWIFT+ BT23 FDA UDI
Model / Reference
Voluson SWIFT EUDAMED
H43222LR EUDAMED
SWIFT+ BT23 FDA UDI
Description
Voluson SWIFT+ BT23 FDA UDI

Identifiers

Catalog Number
5919111 FDA UDI
Primary DI / UDI-DI
00195278560155 EUDAMEDFDA UDI
Basic UDI-DI
8406821BUG00293HP EUDAMED
Direct Marketing DI
00195278560155 EUDAMED
510(k) Number
K230346 FDA UDI
FDA Product Code
ITX FDA UDI
IYN FDA UDI
IYO FDA UDI
EMDN Code
Z11040105 OBSTETRIC/GYNAECOLOGICAL ULTRASOUND SCANNERS EUDAMED
GMDN Term
General-purpose ultrasound imaging system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.1550 FDA UDI
892.1560 FDA UDI
Market of Registration
Austria 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
MRI Safety
MR Unsafe FDA UDI

Voluson SWIFT+ by Ge Ultrasound Korea, Ltd. — Class IIa — 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
GE Ultrasound Korea, Ltd.
EUDAMED SRN
KR-MF-000001860
Authorised Representative
GE Medical Systems SCS FR-AR-000000344

Sources (3)

  • EUDAMED 6306bc70-3028-4288-b5ad-72e28624f95c 61 fields · synced Jul 13, 2026
  • FDA UDI 9dc06dd1-7302-4834-9d89-0c0d84bee827 37 fields · synced May 30, 2026
  • EUDAMED f5052b58-840f-48de-9261-086bd23cc60a 61 fields · synced Jul 13, 2026