← Back to catalogue

Iot332

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 121011100

by Esaote S.p.A.

Identity

Trade Name
IOT332 EUDAMEDFDA UDI
Generic Name
Surgical ultrasound imaging transducer FDA UDI
Device Name
IOT332 EUDAMED
Model / Reference
121011100 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08056304451491 EUDAMEDFDA UDI
Basic UDI-DI
B-08056304451491 EUDAMED
FDA Product Code
ITX FDA UDI
EMDN Code
Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
GMDN Term
Surgical 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
Sterilization Method
Ethylene Oxide FDA UDI

Iot332 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Esaote S.p.A.
EUDAMED SRN
IT-MF-000019024

Sources (2)

  • EUDAMED b8ce3929-7f46-4a0b-b91f-0d5ea7ece905 61 fields · synced Jul 9, 2026
  • FDA UDI 4ae22d1c-4036-4f8b-9315-dafa8ad20278 32 fields · synced May 30, 2026