EUDAMED last updated this device on Mar 4, 2025

100640085

805630445ESA.US0000001.XT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Esaote S.p.A.
UDI-DI code: 08056304455147
Reference / catalog number: 100640085

100640085 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Esaote S.p.A.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on Mar 4, 2025

100640085

805630445ESA.US0000001.XT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Esaote S.p.A.
UDI-DI code: 08056304455147
Reference / catalog number: 100640085

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 08056304455147
Basic UDI-DI: 805630445ESA.US0000001.XT
Reference / catalog number: 100640085
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://eifu.esaote.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08056304455147

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z11040104MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Italy; available across 32 countries total.

Country	On market since	Until
ItalyPrimary placement	Aug 24, 2021	Still on market
Austria	Aug 24, 2021	Still on market
Belgium	Aug 24, 2021	Still on market
Bulgaria	Aug 24, 2021	Still on market
Cyprus	Aug 24, 2021	Still on market
Czechia	Aug 24, 2021	Still on market
Germany	Aug 24, 2021	Still on market
Denmark	Aug 24, 2021	Still on market
Estonia	Aug 24, 2021	Still on market
EL	Aug 24, 2021	Still on market
Spain	Aug 24, 2021	Still on market
Finland	Aug 24, 2021	Still on market
France	Aug 24, 2021	Still on market
Croatia	Aug 24, 2021	Still on market
Hungary	Aug 24, 2021	Still on market
Ireland	Aug 24, 2021	Still on market
Iceland	Aug 24, 2021	Still on market
Liechtenstein	Aug 24, 2021	Still on market
Lithuania	Aug 24, 2021	Still on market
Luxembourg	Aug 24, 2021	Still on market
Latvia	Aug 24, 2021	Still on market
Malta	Aug 24, 2021	Still on market
Netherlands	Aug 24, 2021	Still on market
Norway	Aug 24, 2021	Still on market
Poland	Aug 24, 2021	Still on market
Portugal	Aug 24, 2021	Still on market
Romania	Aug 24, 2021	Still on market
Sweden	Aug 24, 2021	Still on market
Slovenia	Aug 24, 2021	Still on market
Slovakia	Aug 24, 2021	Still on market
Türkiye	Aug 24, 2021	Still on market
XI	Aug 24, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08056304455147
Basic UDI-DI: 805630445ESA.US0000001.XT
Reference / catalog number: 100640085
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://eifu.esaote.com/
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Esaote S.p.A.
SRN: IT-MF-000019024
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08056304455147

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z11040104MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

G10 095545 0024Issued
Quality management systemNotified body: 0123Expiry: Aug 24, 2026

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by Esaote S.p.A.

Market distribution

Primary placement in Italy; available across 32 countries total.

Country	On market since	Until
ItalyPrimary placement	Aug 24, 2021	Still on market
Austria	Aug 24, 2021	Still on market
Belgium	Aug 24, 2021	Still on market
Bulgaria	Aug 24, 2021	Still on market
Cyprus	Aug 24, 2021	Still on market
Czechia	Aug 24, 2021	Still on market
Germany	Aug 24, 2021	Still on market
Denmark	Aug 24, 2021	Still on market
Estonia	Aug 24, 2021	Still on market
EL	Aug 24, 2021	Still on market
Spain	Aug 24, 2021	Still on market
Finland	Aug 24, 2021	Still on market
France	Aug 24, 2021	Still on market
Croatia	Aug 24, 2021	Still on market
Hungary	Aug 24, 2021	Still on market
Ireland	Aug 24, 2021	Still on market
Iceland	Aug 24, 2021	Still on market
Liechtenstein	Aug 24, 2021	Still on market
Lithuania	Aug 24, 2021	Still on market
Luxembourg	Aug 24, 2021	Still on market
Latvia	Aug 24, 2021	Still on market
Malta	Aug 24, 2021	Still on market
Netherlands	Aug 24, 2021	Still on market
Norway	Aug 24, 2021	Still on market
Poland	Aug 24, 2021	Still on market
Portugal	Aug 24, 2021	Still on market
Romania	Aug 24, 2021	Still on market
Sweden	Aug 24, 2021	Still on market
Slovenia	Aug 24, 2021	Still on market
Slovakia	Aug 24, 2021	Still on market
Türkiye	Aug 24, 2021	Still on market
XI	Aug 24, 2021	Still on market

100640085

100640085

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

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