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EA2-11ARn

by Samsung Medison Co., Ltd

Model Ultrasound probe

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800289979224 UDI-DI Date20 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number880972578USP001WH Basic UDI-DI 08800289979224UDI-DIDate16 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Rectal/vaginal ultrasound imaging transducer
Model / Reference
Ultrasound probe EUDAMED
USP-EF2BFNB/WR GUDID
Primary DI / UDI-DI
08800289979224
Basic UDI-DI
880972578USP001WH
FDA Product Code
IYN, IYO, ITX, LLZ, QIH
EMDN Code
Z1104020201 Endocavitary ultrasound probes, two–dimensional
GMDN Term
Rectal/vaginal ultrasound imaging transducer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1550, 892.1560, 892.1570, 892.2050
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Ultrasound probe
GUDID
USP-EF2BFNB/WR
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000011620
Authorised representative
Samsung Electronics GmbH DE-AR-000007005

Other devices from Samsung Medison Co., Ltd.

See all devices from Samsung Medison Co., Ltd. →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No