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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

CUS1000MF012 — Class I MDR by COMEDICAL S.r.l.

MD Atlas
COMEDICAL S.r.l.

EUDAMED last updated this device on May 7, 2026

CUS1000MF012

805527154CUSKX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: COMEDICAL S.r.l.
UDI-DI code: 08055271540030
Reference / catalog number: CUS1000MF012

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View device family (Basic UDI)

Manufacturer information

Organization name: COMEDICAL S.r.l.
SRN: IT-MF-000019319
Manufacturer status: Active

Related devices

CEG1000MF012805527154CEGHPOn the market CUSC1000MF012805527154CUSCE5On the market CEG5000MS002805527154CEGHPOn the market CUD0250MF036805527154CUDWDBJOn the market CUSC5000MT002805527154CUSCE5On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

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: not provided
UDI-DI code: 08055271540030
Basic UDI-DI: 805527154CUSKX
Reference / catalog number: CUS1000MF012
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
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)08055271540030

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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.

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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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