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Ec123

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 9600157000

by Esaote S.p.A.

Identity

Trade Name
EC123 EUDAMEDFDA UDI
Generic Name
Rectal/vaginal ultrasound imaging transducer FDA UDI
Device Name
EC123 EUDAMED
Model / Reference
9600157000 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08056304451958 EUDAMEDFDA UDI
Basic UDI-DI
B-08056304451958 EUDAMED
FDA Product Code
ITX FDA UDI
EMDN Code
Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
GMDN Term
Rectal/vaginal ultrasound imaging 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

Ec123 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 0dced661-967a-428c-907e-fa1314f69c36 61 fields · synced Jun 18, 2026
  • FDA UDI 254dfaaf-47fa-45f8-82e5-0ca9ff32deae 32 fields · synced May 30, 2026