← Back to catalogue

S5mcw

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 121201100

by Esaote S.p.A.

Identity

Trade Name
S5MCW EUDAMEDFDA UDI
Generic Name
Noninvasive vascular ultrasound system probe FDA UDI
Device Name
S5MCW EUDAMED
Model / Reference
121201100 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08056304451590 EUDAMEDFDA UDI
Basic UDI-DI
B-08056304451590 EUDAMED
FDA Product Code
ITX FDA UDI
EMDN Code
Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
GMDN Term
Noninvasive vascular ultrasound system probe 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

S5mcw 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 b36ff41a-0dd8-47d1-95bf-70540a8fecc1 61 fields · synced Jun 18, 2026
  • FDA UDI fc8f5fa9-15bc-4173-a25a-0955c9dc10a6 32 fields · synced May 30, 2026