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Be1123

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 411403

by Esaote S.p.A.

Identity

Trade Name
BE1123 EUDAMEDFDA UDI
Generic Name
Rectal ultrasound imaging system transducer FDA UDI
Device Name
BE1123 EUDAMED
Model / Reference
411403 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08056304451293 EUDAMEDFDA UDI
Basic UDI-DI
B-08056304451293 EUDAMED
FDA Product Code
ITX FDA UDI
EMDN Code
Z1104020202 ENDOCAVITARY ULTRASOUND PROBES, MULTIDIMENSIONAL EUDAMED
GMDN Term
Rectal ultrasound imaging system transducer FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Market of Registration
Italy 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

Be1123 by Esaote S.p.A. — Class IIa — 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
Esaote S.p.A.
EUDAMED SRN
IT-MF-000019024

Sources (2)

  • EUDAMED ae6bc331-d7a9-4ae9-a920-1321cd08d523 61 fields · synced Jun 19, 2026
  • FDA UDI 22a33df3-3118-4394-a592-da306c728a5d 32 fields · synced May 30, 2026