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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

EVOLYSE STRONG 2L — Class IIa MDR by Amil Care Italia S.r.l.

MD Atlas
Amil Care Italia S.r.l.

EUDAMED last updated this device on May 27, 2026

EVOLYSE STRONG 2L

805664647EL23sD2

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Amil Care Italia S.r.l.
UDI-DI code: 08056646470341
Reference / catalog number: 2020.23

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View device family (Basic UDI)

Manufacturer information

Organization name: Amil Care Italia S.r.l.
SRN: IT-MF-000012107
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: EVOLYSE STRONG 2L
UDI-DI code: 08056646470341
Basic UDI-DI: 805664647EL23sD2
Reference / catalog number: 2020.23
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: 6
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
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)08056646470341

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UDI-PI DataMatrix

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

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EMDN nomenclature code(s)

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

D0502HYDROGEN PEROXIDE FOR DISINFECTION OF MEDICAL DEVICES

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

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Certificates

Certificate health across this manufacturer's portfolio.

083-00-00-MDRIssued
Quality management systemNotified body: 0426Expiry: Oct 13, 2030

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