EUDAMED last updated this device on Jul 17, 2026

COLLARE EUSOFT ZERO IMPACT MED ALTO CM8 EU008E MIS. M - CONF. DA 1 PZ.

805659855DT022DX

On the marketClass I

Applicable legislation: —
Organization name: EUMEDICA SRL
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08056598552287
Reference / catalog number: EU008ME

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

COLLARE EUSOFT ZERO IMPACT MED ALTO CM8 EU008E MIS. M - CONF. DA 1 PZ. is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by EUMEDICA SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: COLLARE EUSOFT ZERO IMPACT MED ALTO CM8 EU008E MIS. M - CONF. DA 1 PZ.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08056598552287
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 805659855DT022DX
Reference / catalog number: EU008ME
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: Eusoft Neck Brace Orthopedic neck brace made of soft polyurethane with an adjustable Velcro closure. Indications Arthritic and inflammatory neck pain - mild neck sprains
Additional information URL: https://www.eumedica.it/
Clinical sizes: M - ALTO 8 CM

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08056598552287

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.

Y060312CERVICAL SPINE ORTHOSES

Critical warnings

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

Consult instructions for use

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	—	Still on market

COLLARE EUSOFT ZERO IMPACT MED ALTO CM8 EU008E MIS. M - CONF. DA 1 PZ.

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Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

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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

Regulatory

Lifecycle

Certificates

Certificates covering this device

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Manufacturer information

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Certificates