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Ec1123

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 411312

by Esaote S.p.A.

Identity

Trade Name
EC1123 EUDAMEDFDA UDI
Generic Name
Rectal ultrasound imaging system transducer FDA UDI
Device Name
EC1123 EUDAMED
Model / Reference
411312 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08056304451279 EUDAMEDFDA UDI
Basic UDI-DI
B-08056304451279 EUDAMED
FDA Product Code
ITX FDA UDI
EMDN Code
Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL 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

Ec1123 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 14944e95-cfb6-4788-85e4-70d7ed29f871 61 fields · synced Jul 26, 2026
  • FDA UDI 8a1c3a78-1709-49bc-b290-f0d3584547c1 32 fields · synced May 24, 2026